The Registration Of Medical Devices, Conformity Assessment, Distribution, Operation And Technical Monitoring Procedures

Original Language Title: Medicīnisko ierīču reģistrācijas, atbilstības novērtēšanas, izplatīšanas, ekspluatācijas un tehniskās uzraudzības kārtība

Read the untranslated law here: https://www.vestnesis.lv/ta/id/114588

Cabinet of Ministers Regulations No. 581 Riga, 2 august 2005 (pr. No 44 § 2) registration of medical devices, conformity assessment, distribution, operation and technical supervision order Issued in accordance with article 34 of the law on medical treatment and the law "on conformity assessment" article 7 of the first and the second part 1. General questions 1. sets out procedures for the taking of goods and medical devices (medical devices), conformity assessment, as well as their distribution, operation and technical surveillance.
2. the competent institution of medical device registration, operation and monitoring of the distribution of the health statistics and medical technologies State Agency (hereinafter the Agency).
3. compliance with the medical devices assessed institution accredited by the National Accreditation Bureau of Latvia in accordance with the law on conformity assessment "and that the accreditation of the Ministry of economy has published a notice in the newspaper" journal ", and for which the authorisation is to evaluate compliance with the announced the European Commission (hereinafter referred to as the notified body), as well as other Member States of the European Union of conformity assessment bodies, the European Commission has stated as such (notified bodies of the European Union within the meaning of the law).
4. Medical devices (with the exception of medical devices, in vitro diagnostic) are divided into the following classes: I, IIA, IIb and III. Medical devices are classified in accordance with the provisions of annex 1. Medical devices, in vitro diagnostic (hereinafter referred to as in vitro diagnostic devices), list A list B devices, devices, inspection equipment, other (other) devices and devices for performance evaluation, in accordance with the provisions of annex 2. Where domstar pīb incurred on the application of the classification rules, the matter shall be determined by the Agency.
5. medical devices may be put into circulation, they shall draw up a declaration of EKatbilstīb and they are marked with the CE conformity marking (CE marking) (annex 3). This condition does not apply to medical devices: 5.1 which is made to order;
5.2. What are medical devices intended for clinical investigations;
5.3. What is performance evaluation of medical devices for use in in vitro diagnosis;
5.4. where these rules do not meet the essential requirements laid down;
UR5.5.kur s not done the necessary conformity assessment procedures.
6. the CE marking is clearly visible, clearly legible and indelible, easily accessible and located prominently on the medical device or its sterile packaging or marketing, as well as to the instructions for use.
7. together with the CE mark, class I sterile medical devices and medical devices with a measuring function, the IIA, IIb and III devices at niskaj, medic, active implantable medical devices, A list, Bsarakst and self-test medical devices, in vitro diagno so indicates the assessment of conformity of the notified body involved in the identification number assigned to it by the European Commission.
8.Uz medical devices, its sterile packaging or marketing, as well as to the instructions for use can be deployed to any other mark provided that the CE marking remains visible and legible. The use of marks or inscriptions which are likely to mislead third parties with regard to the CE marking.
9. Medical devices that meet the national standard status in the European harmonised adapted standards (applicable standards), which is published in the Official Gazette of the references in the official journal of the European Union, or common technical specifications for in vitro-diagnostic device complies with the essential requirements. The Agency, based on the relevant European standards technical Committee of the Commission of the findings and decision of the European Commission, recommends that the society with limited liability "standard" European Union reliance standard. Limited liability company "Latvian standards" submit for publication in the newspaper "journal," the Latvian National Standard status in the list of applicable standards adapted to the applicable requirements of these rules.
10. the meaning of these provisions these regulations referred to in paragraph 9, the publication also includes the monographs of the European Pharmacopoeia, including those relating to surgical sutures and on interaction between medicinal products and materials used in medical devices containing such medicinal products, and the references of which have been published in the official journal of the official journal of the European Union.
11. the construction, operation and safety of custom-made medical devices can detect not only doctors, but also any person who has the appropriate professional qualifications.
12. Custom-made medical device is a medical device made in accordance with the instructions of doctors and is intended only for one particular patient. Custom-made medical devices are not mass produced devices which are adapted to meet the doctor or other professional specialists of the specific requirements laid down.
13. the obligations laid down in these rules, imposed on manufacturers of medical devices, also apply to persons assembled, packaged, processed, renewed, or highlight one or more ready-made medical devices and determine for what purpose these medical devices are intended to be put into circulation. This condition does not apply to persons who assemble or adjusted if the circulation of medical devices for use in certain patients.
14. If a medical device is intended for the Republic of Latvia register of medicinal products registered medicines, subject to these rules.
15. If a medical device as an integral part of the substance, which includes using separately, may be considered to be a medicinal product constituent or a medicinal product or a medicinal product derived from human blood or plasma and which is liable to act upon the human body, helping device to achieve the desired outcome, then the electronic check in before such medic device registration medicine State Agency at the request of the Agency shall evaluate such products and provide an opinion to the Agency : UR15.1.par for registration in the product submitted substances compliance with or from human blood and plasma, the definition of medicinal products;
15.2. the medical device that includes drugs, meet the requirements set out in the introductory paragraph.
16. These provisions shall not apply to: 16.1. medicinal products from human blood and plasma-derived medicinal products;
16.2. human blood, blood products, plasma, human blood cells and medical devices with such blood products, plasma or cells is at a time when these devices are put into circulation, except for medical devices referred to in paragraph 15 of these rules;
16.3. cosmetic products;
16.4. the individual (personal) protective equipment, which do not apply to health care;
16.5. medical devices marketed in such a way that the device and the medicinal product form a single product intended for use in single and only in the given combination and which is not multiple.
17.Uz this rule 16.5. devices referred to in subparagraph applies these rules contain the essential requirements for medical devices and security, and they recorded the State Agency of medicines.
18. in order to determine whether a medical device subject to these rules, having regard to the objective, for a particular medical device manufactured and designed.
19. the information available to users and patients so that they can use the medical device according to its intended purpose, is the national language, unless these rules otherwise.
20. Medical device can register and be put into circulation only if you meet all the essential requirements set by these rules, and has carried out the conformity assessment procedure notified body (point 7 of these rules in medical devices).
21. the Agency does not track the provisions referred to in paragraph 15 of the medical device, if the ingredients accordingly to specific medicinal products or substances, is not registered in the Republic of Latvia register of medicinal products. Does not include medical devices incorporating, as an integral part of included substances which comply with the drug or from human blood and plasma, the definition of a medicinal product, if the product is not registered in the Republic of Latvia or the centralised registration procedures in the European Union, or the registration of which is not valid, or is not scientific medicine State Agency's opinion that a particular substance is not dangerous to its users.
2. Medical devices sliding essential requirements 2.1 General requirements

22. This chapter is specific medical devices essential requirements raised for their construction, operation and safety. With medical devices understand instruments, apparatus, appliances, materials or other items that are used alone or in combination with any other devices, including the software necessary for parties to use the device as intended by the manufacturer, to diagnose, prevent, monitor, treat, or alleviate disease, diagnose, monitor, treat, or compensate for the injuries or physical deficiencies, study, or modify the person replacing the body's structure or physiological processes , control the birth rate, and the intended effects on persons not achieved with pharmacological, immunological and metabolic means, but which may be assisted in its function by such means. Items that are not medical devices, but which is specifically intended by the manufacturer for use with a medical device, ensuring that the device is used according to the manufacturer of the device for its intended purpose, the meaning of these provisions are considered to be medical devices.
23. The provisions of this chapter shall not apply to active implantable medic in niskaj devices and in vitro diagnostic devices.
24. Medical devices designed and built in such a way that using the intended purpose according to the manufacturer's instructions for use, provided they do not result in injury to the patient, user and third-party health and life.
25.Ar medical device risks are proportionate to the benefits.
26. the manufacturer of medical devices used in the development and construction of address you correspond to the medical device and security principles, based on the latest achievements of the sector concerned.
27. the manufacturer choosing solutions development and medical equipment for the construction, adhere to the following principles: to reduce the risk of use 27.1.;
27.2. the protective measures;
16.3. use alarm signals as regards imminent threats;
27.4. to inform the user of any shortcomings in the protection arrangements, which creates an imminent threat.
28. The overload that medical device may occur in everyday use conditions laid down by the manufacturer of the medical device during use, must not adversely affect this rule 24, 25, 26 and 27 of those requirements in a way that is compromised patient, user, or third-party health or life.
29. the development in the medical device, produced and packed in the transport and storage, follow the instructions specified by the manufacturer and in the light of the information provided, it would not be adversely affected in the medical device and security parameters.
30. Any undesirable effects caused by medical device use, is proportionate with the expected medical device performance.
2.2. Development and construction sliding requirements 31. with respect to medical devices, chemical physical and biological characteristics: 31.1. toxicity materials used and flammability;
31.2. the materials used and biological tissues, cells and body fluids compatibility;
UR31.3.lai not subject to the medical device users, patients, and third person in the transport, storage and use of the danger posed by the pollution of the medical device and residue;
19.5. tissue detection duration and frequency;
UR31.5.lai medical devices can be used in conjunction with materials, substances and gases with which they come into contact in normal use or during routine procedures;
UR31.6.lai medical devices intended to administer medicinal products are designed and manufactured in such a way that the medical device should be compatible with the medicinal product;
UR31.7.lai if a medical device as an integral part of include a human blood derivative, taking account of the European Agency for the evaluation of medicinal products (EMEA) scientific opinion on the specific quality and safety of the derivative;
UR31.8.lai from each of the human blood derivative intermediate and finished product batches in sequence, at least one sample would be tested specifically for this purpose in a laboratory designated by the State;
UR31.9.lai reduce to a minimum the risks posed by substances leaking from the medical device, as well as the inflow of the device itself.
32. with regard to infections and pollution caused by micro-organisms adhere to: 32.1. medical devices and their manufacturing processes are designed to minimise the risk of infection to the patient, user and third parties;
32.2. the structure of the medical device may reduce the risk of its use during patient infect medical device and must infect the patient;
UR32.3.dz īvniek tissue are derived from animals that have been subjected to veterinary inspection;
32.4. the Agency and treatment services store information about the geographical origin of the animals;
32.5.ar animal tissues, cells and substances act to ensure security against viruses and other infections caused by portable ERS, the production process with the European Union recognized the virus destruction or inactivation of methods;
32.6. medical devices marketed in a sterile manner, are designed, manufactured and packaged in such a way that the package of trade, abiding in the horse and carriage storage conditions to ensure that the medical device sterility until packaging damage or open;
32.7. medical devices marketed in a sterile State, be manufactured and sterilized under the Republic of Latvia and the European Union recognised methods, as indicated in the applicable standards;
20.4. medical devices intended to be sterilized, are produced in the environmental and hygiene conditions that ensure the sterility of the medical device;
32.9. non-sterile medical devices trade packaging ensure medical device storage so that the medical device does not affect the external environmental factors;
32.10. If this provision 32.9. referred to sterilize medical devices, reduce the risk of contamination caused by micro-organisms and the electronic check in device packaging medic would be suitable for the sterilization indicated by the manufacturer;
32.11. medical device packaging or label to distinguish identical or similar medical devices that are put into circulation in both sterile and non-sterile.
33. with regard to the design of medical devices to: 33.1. If a medical device is intended for use in combination with other medical devices or equipment in the following set, including the connections, be sure and do not worsen the situation of those medical devices;
33.2. in the instructions for use or on the label should indicate all the restrictions on the use of this rule 33.1. referred medical devices or the entire suite;
33.3. medical devices are designed and manufactured by preventing or reducing the possible 33.3.1. injuries: risks related to the physical properties of medical devices, including volume and pressure ratio, the size and the ergonomics of the medical device;
33.3.2. risks related to magnetic fields, external electrical influences, electrostatic discharge, pressure, temperature, and other external conditions;
33.3.3. threat of mutual interference, treatment or investigations using parallel multiple medical devices;
33.3.4. threats arising from ageing of materials used in or in connection with the precision of measuring displacements or control mechanisms, where maintenance or calibration are not possible;
20.8. medical devices are developed and manufactured, reducing the risks of fire or explosion, medical device use according to the manufacturer's instruction for use and medical devices in case of damage.
34. the manufacturer, special attention to the development and production process turns medical devices whose use is intended to come into contact with flammable substances.
35. with regard to medical devices with a measuring function: UR35.1.lai the following medical devices are designed and manufactured to ensure the necessary accuracy and stability within appropriate limits of accuracy, in particular in the light of the purpose for which they are intended;
35.2. specifying limits of accuracy in the instructions for use;
UR35.3.lai measurement, monitoring and display scale must be designed in accordance with ergonomic principles, taking account in particular purpose, any such medical device intended;
UR35.4.lai with such devices, the measurements are expressed in units of measurement corresponds to the European Union or in the Republic of Latvia the applicable standards.
36. with regard to protection against radioactive radiation followed to: 36.1. medical devices are designed and manufactured, potentially reducing the patient, user and third parties, while the radioactive exposure without limiting the doses required for treatment or diagnosis;
36.2. the user should be able to control the radiation, if the medical device is designed for dangerous radioactive to emit, required for a specific medical purpose the benefit is proportionate to the risk of you fell over;

36.3. this rule 36.2. referred to medical devices are designed and manufactured to ensure reproducibility of the essential variables parameters and tolerance;
36.4. medical devices intended to emit potentially hazardous, visible or invisible radioactive to emit, are equipped with a dose of Visual indicator or audible warning systems;
22.7. medical devices are designed and manufactured, potentially reducing the patient, user and third parties to the emission of unintended, stray or scattered for radio exposure.
22.7. instructions for medical devices that emit a radio active radiation should include comprehensive information on the nature of the emitted radiation, the patient, user and third-party protection products, as well as on ways of avoiding the wrong medical equipment use and prevent threats associated with such medical devices;
22.8. medical devices intended to emit ionizing radiation radiates away, be developed and produced, if necessary, controlling and changing the radioactive quantity, geometry and quality, especially in the light of the purpose for which such a medical device is intended;
22.9. medical devices emitting ionising nuclear radiation intended for diagnostic radiology shall be designed and manufactured to get the desired image quality or other desired result with the intended therapeutic purpose, while reducing the patient, user and third parties of the irradiation;
22.9. medical devices emitting ionising radiation radioactive, intended for therapeutic radiology shall be designed and manufactured to ensure radio active radiation dose, the beam type, intensity and quality reliable monitoring and control.
37. with regard to medical devices connected to or equipped with an energy source, to: 37.1. medical devices incorporating electronic programmable systems be developed, ensuring system continuity and regularity, compliance with the intended purpose;
37.2. the electronic programmable systems in case of damage would be a suitable means for potential threats;
37.3. medical devices that use, patient safety depends on an internal power supply be equipped with a means of determining the State of the power supply;
37.4. medical devices that use, patient safety depends on an external power supply is equipped with an alarm system to signal any power failure;
37.5. medical devices intended for one or more clinical parameters of a patient for observation, are equipped with alarm systems that alert the user of situations which could lead to the death of a patient or a significant deterioration in his State of health;
23.4. medical devices are designed and manufactured, potentially reducing the risks of creating electromagnetic fields which could impair the operation of other devices or equipment in the environment;
37.7. medical devices are designed and manufactured, potentially reducing the risk of electric shock when it is used according to the manufacturer's instructions and in the case of damage to a minor;
23.5. medical devices are designed and manufactured to protect the patient, user and third thoughts from mechanical impact caused by medical devices, resistance instability and its moving parts;
23.5. medical devices are designed and manufactured, potentially reducing adverse effects caused by medical devices cause vibration and noise, particularly in the light of technical progress and of the means available to reduce noise, vibration, and (except in the case of vibrations or noise is part of the medical device intended operations);
37.10. jacks and electrical, hydraulic and pneumatic energy supplies nary to be developed and produced, reducing the possible threat they may cause medical devices health and life of users, using the medical device according to the manufacturer's instructions;
37.11. medical equipment parts that come into contact during the use by the user, the patient or a third party (except for the details, which are directly intended to supply heat or reach given temperatures), should not be allowed to heat up to a temperature that is specified in the instructions of the manufacturer, if the medical device is used according to the manufacturer's instructions;
37.12. medical devices that use energy and substances would be developed to provide for the possibility of accurately set and maintain energy or substance flow rate, thus providing the patient, user and third parties ' safety;
37.13. medical devices be equipped with machines that fix each energy or substances dangerous flow rate accuracy or not warn about it;
37.14. medical devices be equipped with devices which prevent the source of energy or substance intended not dangerous amounts of energy or substance in return;
37.15.uz medical devices and the control indicator functions;
37.16. If the medical device is operating instructions or a visual indication of the operating or adjustment parameters, this information should be clearly understood by the user, as well as, if necessary, the patient or third parties.
38. the manufacturer shall provide medical devices to patients and third parties information on: 38.1. manufacturer (name and address);
38.2. the safe use of the medical device, in particular taking into account the expected user knowledge and preparedness (this information includes medical device instructions for use or on the medical device label).
39. information on the safe use of medical devices are indicated on the medical device or its packaging for each unit or on its trade package. If each single medical device wrap is not possible, this information adds more medical devices in the form of a booklet or otherwise, subject to the provision of such information.
40. The instructions for use of each medical device packaging, except for this provision, paragraph 39. Instructions for use is not required for class I and II medical devices, if not a professional goal, which the medical device is intended to be understood without it.
41. the information contained in the instructions for use can consist of symbols, if they (the same as used in the identification of colors) meet the applicable standards established in the Republic of Latvia and the European Union.
42. If devices with medical related field is not applicable, the standard symbols and colors explained instructions for use of the medical device or other medical device added to the document.
43. The medical device label: 43.1. manufacturer's name and address;
43.2. information on medical device characteristics and functions;
43.3. the word "sterile", if the medical device is in a sterile condition;
43.4. medical device batch code assigned by the manufacturer and following the word ' lot ', or the serial number assigned by the manufacturer;
UR43.5.ier īc of a validity period, expressed as the year and month, up to which the medical device is safe to use, if a medical device is a limited life;
UR43.6.nor skin for it, or medical device is for single use;
UR43.7.nor leather "made to order" If the medical device is costum-made;
UR43.8.nor skin ' exclusively for clinical investigations ', if the medical device is intended for clinical investigations;
43.9. any special storage conditions;
43.10. any specific conditions of operation;
43.11. all relevant warnings or safety precautions;
43.12. year of manufacture for those medical devices which are not subject to the provisions of section 43.5. (you can also include a batch or serial number);
43.13. sterilization;
UR43.14.nor skin, or a medical device contains a human blood derivative.
44. If the purpose for which the medical device is intended, not professional is not understood, the manufacturer expressly indicated on the label and in the instructions for use.
45. If you provide medical equipment components (components of) absolute compatibility and connectivity, medical devices and detachable components (components) marked with the batch or serial number assigned by the manufacturer, reducing risk, which may cause medical devices and detachable components.
46. If the information in question may not contain label medical device, medical device, the manufacturer instructions State: 46.1. This provision of the information referred to in paragraph 43;
46.2. the medical device characteristics and function, as well as its use in adverse reactions;
46.3. information on medical device parameters, if it is to carry out its intended functions, installed or connected to other medical devices or equipment;
46.4. the information necessary to verify that the medical device is installed and operated according to the manufacturer's instructions provided for, as well as information about the maintenance and calibration;
46.5. for information on how to avoid the dangers that arise in connection with implantation of the medical device;

46.6. for information on medical equipment the risks of reciprocal interference posed by the resulting specific investigations or treatment;
UR46.7.nor in cases where the setting knob is defective medical device packaging that preserves the sterility of the medical device, as well as the specific medical device corresponding recurrent sterilization methods;
29.1. the information on the application of operation, if the medical device is reusable, as cleaning, disinfection, packaging or sterilized, as well as information about the restriction on the number of times;
UR46.9.nor on how the setting knob to clean and sterilised medical devices, if it is intended to be sterilized prior to use according to the manufacturer's instructions;
UR46.10.nor the setting knob on the specific activities carried out before the usage of the medical device;
46.11. information about radioactive nature, type, intensity and field if the medical device is intended to emit radioactive radiation for medical purposes;
46.12. information about any possible contra-indications;
46.13. information about all the precautions to be taken, which include: 46.13.1. the precautionary measures taken by the medical device for changes;
46.13.2. the precautionary measures in relation to magnetic fields, external electrical power, electrostatic discharge, pressure, pressure, acceleration, thermal ignition sources, and other effects that may occur under foreseeable environmental conditions;
46.13.3. information on the medicinal products concerned by the medical device is intended to administer, including any limitations on ievadāmaj substances;
46.13.4. the precautionary measures taken in order to avoid any hazards, medical device, destroying;
46.13.5. the components of the medical device in accordance with the provisions of article 15;
46.13.6. medical devices with a measuring function accuracy level.
47. If the conformity with the essential requirements based on clinical data, this data shall be determined in accordance with the laws and regulations governing persons medical device clinical trial procedures.
3. Active implantable medical devices sliding essential requirements 3.1 General requirements 48. This chapter describes the active implantable medical devices, sliding the essential requirements for the construction, operation and safety. With active implantable medical devices understand all the medical device that depends on the functioning of the electrical energy sources or other energy sources that do not directly generated by the human body or gravity and which are intended to be totally or partially, or to insert a surgical medical or human body, medical intervention, the body's natural opening, and which is intended to remain after the procedure.
49. An active implantable medical device designed and made so that, when its implantēj according to the manufacturer's instructions provided with the device for the intended purpose, their use does not impair the clinical condition or the safety of the patients. Active implantable medical devices do not pose a threat to the persons implanting them, as well as third parties.
50. The rules referred to in paragraph 49 of the characteristics and activities of arbitrarily does not affect patient or other individual clinical condition and security, compromising their active implantable medical devices during operation, which is foreseen by the manufacturer, if the active implantable medical device daily conditions of use are subject to voltage.
51. An active implantable medical device is developed, produced and packaged, stored and transported as well as according to the manufacturer's specified storage and transporting of circumstances, does not impair the active implantable medical device usage efficiency.
52. Active implantable medical device adverse reactions are caused by disproportionate to its benefits for the patient.
3.2. Design and construction of sliding requirements 53. Active implantable medical device development and manufacturing solutions are used by the manufacturer, conform to the principles of security, containing the industry's latest developments.
54. the development of active implantējamasmedicīnisk device, manufactured and packaged in a trade package, ensuring that at the time of release for consumption, they should be sterile and, within the manufacturer's specified storage and transport conditions, they would, until going to ņojum and open the implant.
55. Active implantable medical devices developed and produced, potentially eliminating or reducing the possibility for active: 55.1. implantable medical device to harm its physical properties (size);
55.2. threats that can lead to insufficient power source insulation, leakage current and active implantable medical devices overheat;
55.3. possible threats caused by magnetic fields, electric fields, electrostatic discharge, pressure or variations in pressure and Acceleration, as well as other foreseeable environmental conditions;
55.4. risks that relate to the treatment process, in particular those resulting from defibrillator or high-frequency surgical equipment;
55.5. risks that relate to active implantable medical devices include ionizing radiation, radioactive substances;
57.5. threats that may result from the fact that it is not possible for the active implantable medical device of maintenance and calibration, including: excessive leakage current 55.6.1.;
55.6.2. the deterioration of the materials used;
55.6.3. medical device generated excessive heat;
55.6.4. medical devices with a measuring function or control devices precision degradation.
56. with regard to active implantable medical devices design and construction: 56.1. materials used and their toxicity;
56.2. materials used and of tissue, cells and liquid mutual compatibility, especially taking into account the active implantable medical devices;
UR56.3.akt array of implantable medical devices compatibility with substances and typing the dosage it is intended;
56.4. connection quality and energy sources of the active implantable medical device security;
UR56.5.lai of active implantable medical devices should not leak;
56.6. hardware and control system for proper operation.
57.Uz active implantable medical devices and, if necessary, to compress the ingredients are signs of measures to be taken if the active implantable medical device or its components, the user or the patient threatened a third party health or life.
58.Uz active implantable medical devices deploys agency or another European Union Member State competent authorities, the notified body or by the manufacturer of the digital code that makes it possible to find out the manufacturer, type and year of manufacture. The digital code can be read without surgical intervention.
59. If on active implantable medical devices, its components or accessories placed an instruction manual or labels that indicate the operating and control parameters, the following information is displayed so that you can understand the user and the patient, taking into account their level of training and active implantable medical devices.
60.Uz each of the active implantable medical device sterile wrapped you deploys a clearly legible and indelible information (if necessary, recognition of the symbol, which are contained in the applicable standards), which include: 60.1. sterilization;
UR60.2.nor skin that packaging is sterile;
60.3. the name and address of the manufacturer;
UR60.4.akt array of implantable medical device characteristics and function, 37.6. the words "only in clinical research", if the active implantable medical device is intended for clinical investigations;
60.6. the words "made to order" if active implantable electronic check in at the medic device is costum-made;
60.7. European Union atzītumarķējum, which shows that the active implantable medical device is in a sterile condition;
UR60.8.akt array of implantable medical devices the year and month of manufacture;
60.9. date until which the active implantable medical device can be safely implanted.
61.Uz each of the active implantable medical device sales packaging placed in a clearly legible and indelible information (if needed, compress the appearance of recognised symbol), which include: 61.1. manufacturer's name and address;
UR61.2.akt array of implantable medical device characteristics and function, essential use 38.1. parameters;
61.4. the words "only in clinical research", if the active implantable medical device is intended for clinical investigations;
61.5. the words "made to order", if the active implantable medical device is costum-made;
UR61.6.mar ķējum, which shows that the active implantable medical device is in a sterile condition;
UR61.7.akt array of implantable medical device of the year and month of manufacture;
38.4. the deadline by which the active implantable medical device can be safely implanted;
UR61.9.akt array of implantable medical devices and keep the horse transport conditions.
62. for each active implantable medical device which is placed on the circulation, add instructions, which shall contain the following information:

UR62.1.nor skin for years, when granted permission active implantable medical device labelled with CE marking;
62.2.60. these provisions and the information referred to in paragraph 61 (except 60.9 60.8. and information referred to in paragraph);
38.7. information about any possible adverse reactions;
38.8. information that allows a doctor to identify and select the best active implantable medical device, software and accessories;
UR62.5.nor skin-doctors (in some cases, patients) on active implantable medical devices, accessories and software according to the particular features of the device;
38.9. information that allows to avoid the threat of a device implantation;
62.7. information on the possible delay between (the investigation or treatment instrument used on adverse effects on active implant medical device or tējam the same active implantable medical device by exposure to these instruments) that active implanted medical devices may lead to specific investigations or treatment;
39.0. required indications in cases of damage to active implantable medical devices sterile packaging and, where possible, information on the appropriate methods of resterilization;
39.1. where appropriate, an indication of the active implantable medical device reuse only if it has been updated and referred to in this Chapter comply with the essential requirements;
35.10. information about any possible contra-indications and precautions the ERS;
UR62.11.nor skin for life energy source;
62.12. information on precautionary measures, if the active implantable medical device observed unexpected changes;
62.13. information on precautionary measures, if the active implantable medical device enters the magnetic fields, external electrical field, electro static discharge, pressure or acceleration, as well as other foreseeable environmental conditions;
No 62.14. required information about medicinal products intended to be given, using the specific active implantable medical device.
4. In vitro diagnostic devices sliding essential requirements 4.1 General requirements 63. This chapter is specific in vitro diagnostic devices for sliding the essential requirements for the construction, operation and safety. With in vitro diagno devices will understand that the medical device is reactive, reactive products, calibrators, control material, Kit, instrument, equipment or system, whether used alone or in combination with other medical devices, and by the manufacturer for use in vitro diagnosis, to study from the human body for specimens, including blood and tissue passed, only or mainly gathering information concerning a physiological or pathological State or congenital abnormality of the or to determine the safety and compatibility with potential recipients, or therapeutic activities. General usage in the laboratory products are not in vitro diagnostic device, if the manufacturer of such products, given their characteristics, are not particularly intend to use in vitro diagnostics. Accessories means devices intended specifically by the manufacturer to be used together with some medical devices, in vitro diagnostic, to ensure that the device is used according to its intended purpose.
64. These rules, calibration and control materials, for determining the device manufacturer, refer to any substance, material or article intended by their manufacturer either to establish measurement relationships or to test in vitro diagnostic device performance characteristics of its design.
65. This section lists the essential requirements also apply to in vitro diagnostic devices that are developed and manufactured in accordance with the applicable standards (technical) identified in relation to this provision of the annex 2 list in vitro diagnostic devices and these rules in exceptional cases, on the B list in vitro diagno so devices. The manufacturer shall comply with the standards, but if they justified reasons, these standards cannot be met, these solutions in a manner that maintains the in vitro diagnostic devices, which are similar to the standards.
66.In vitro diagnostic devices developed and produced so that using it according to the manufacturer's instructions, they set out not to cause harm to the patient, the user, as well as third-party life, limb and property. The risk to which the patient is exposed to when using a specific in vitro diagnostic device that is proportionate to the benefit of the patient.
67. the measures adopted by the manufacturer of the in vitro diagnostic device development and design solutions to meet the safety principles, taking account of the latest developments in the sector concerned.
68.In vitro diagnostic devices take steps, as specified by the manufacturer (including analytical, diagnostic sensitivity sensitivity, analytical specificity, diagnostic specificity, accuracy, repeatability, unknown interference control and detection of Kona limit). The ability to track the values assigned to calibrators or controls the materials provided through available reference measurement procedures of ces or the available higher order control materials.
69. If an in vitro diagnostic device use in everyday circumstances, is subject to voltage, its activities and functions should not be arbitrarily influence that is compromised patient, user, or third-party health or life of the device specified by the manufacturer of the time. If the use of the term by the manufacturer in accordance with these rules is not detected, take note of the specific types of in vitro diagnostic devices under normal use of the term.
70.In vitro diagnostic devices developed and produced it, transport and storage conditions that are specified by the manufacturer, does not adversely affect the in vitro diagnostic devices and functions, using them according to the intended purpose.
4.2. Design and construction of sliding requirements 71. For in vitro diagnostic devices for chemical and physical properties: UR71.1.lai in vitro devices are designed and manufactured to ensure activities and functions under 4.1. sub-chapter conditions;
71.2. analytical interference, due to incompatibility between the materials used and the sample according to the purpose of acquisition is intended for use in vitro diagnostic device;
UR71.3.lai in vitro diagnostic devices are designed, manufactured and packed, potentially reducing the potential threat to persons engaged in the transport and storage of the equipment or its use may cause leakage, pollution or their actions.
72. with regard to infections and microbiological pollution, which can lead to in vitro diagnostic devices, to: 72.1.in vitro diagnostic devices and their manufacturing processes are developed, eliminating or reducing the possible patients, users and third parties infection;
72.2.in vitro diagnostic device structure ensure easy handling and, where necessary, reduce to pollute or contaminate in vitro diagno so device and in vitro diagnostic device, the ability to infect the patient during operation (this also applies to the sample containers-in vitro diagnostic devices that can also be vacuum devices and which are from the human body for inclusion and storage of samples in vitro diagnostic purposes of investigation);
72.3. If an in vitro diagnostic device containing biological substances may reduce the patient, user and third parties the risk of infection by selecting appropriate donors and substances, as well as using inactivation, conservation, test and control procedures;
72.4. in vitro diagnostic devices, which, putting them on the market, hosted "sterile", or in vitro diagnostic device, having a special microbiological State, be developed, produced and processed according to recognized methods and packaged in suitable packaging, stored on the in vitro diagnostic devices the label special microbiological State according to the manufacturer's specified storage and transport conditions, until the said packaging damage or open;
72.5.in vitro diagnostic devices (except this rule 72.4. devices referred) in packaging systems ensure conservation, without lowering the level of purity ex (external factors), and if the in vitro diagnostic device is sterilized prior to use, minimise the risk of contamination mikrobiol logical;
If microbiological pollution 72.6 at. may adversely affect the in vitro diagnostic device, the measures to be taken, which may reduce the risk of microbiological contamination of in vitro diagnostic devices in the selection of raw materials and transport, manufacturing, storage and distribution;
72.7. sterilisable in in vitro diagnostic devices are manufactured using recognized control methods;

72.8. non-sterile in vitro diagnostic devices for commercial packaging ensure the purity level specified by the manufacturer (external factors) and if they are sterilized prior to use, minimise the risk of microbiological contamination;
45.3. the packaging would fit the manufacturer's prescribed method of sterilization.
73. For in vitro diagnostic devices the conditions of production for: 73.1. If in vitro diagnostic device is intended for use in combination with other devices or equipment, this set, including the connection system, be sure and do not aggravate the situation of in vitro diagnostic devices (any of the passengers using the consumer on the label or in the instructions for use);
73.2.in vitro diagnostic devices are designed and manufactured, potentially reducing the risk associated with in vitro diagnostic devices for use in conjunction with materials, substances and gases with which they may come into contact, they use per design;
73.3.in vitro diagnostic devices are designed and manufactured by preventing or reducing the risk of possible in vitro diagnostic device in their physical characteristics (size) to cause health damage;
73.4.in vitro diagnostic devices are designed and manufactured by preventing or reducing the possible risks related to magnetic fields, external electrical effects, electrostatic discharge, pressure, humidity, temperature, pressure, acceleration of movement of a substance or accidental penetration in vitro diagnostic device;
73.5.in vitro diagnostic devices ensure adequate elektromagn of international interference in internal protection that keeps the in vitro diagnostic device functions;
73.6. reduce the in vitro diagnostic devices, fire or explosion risk when it is used according to the manufacturer's instructions for use and in case of damage;
73.7.in vitro diagnostic devices are designed and manufactured by promoting safe waste management organization;
73.8.in vitro diagnostic devices the measuring, monitoring or display scale (including colour and other Visual indicators) are designed and manufactured in accordance with accepted principles of ergonomic, taking particular account of the in vitro diagnostic devices for functions.
74. For in vitro diagnostic devices that are added to the instrument or apparatus with a measuring function, to: 74.1. in vitro diagnostic device, which is the main analytical measuring function, are designed and manufactured to ensure the stability of the measurements and product zitāt, taking account of in vitro diagnostic device features and available reference measurement procedures and materials;
74.2. If the values are expressed in numerical form, they are noted in the officially recognized units laid down in the applicable standards.
75. as regards protection against radioactive radiation, emitting the in vitro diagnostic devices, to: 75.1.in vitro diagnostic devices are designed, manufactured and packed, potentially reducing the users and third parties with exposure to nuclear radiation;
75.2. If an in vitro diagnostic device function composed of dangerous radioactive radiation radiation doses, in vitro diagnostic devices are designed and produced, providing the ability to control radiation parameters, and is equipped with a Visual indicator or audible warning systems;
75.3.in vitro diagnostic device, which emits radioactive radiation, instructions should include information on the nature of the emitted radiation, radioactive protection products, opportunities to escape from in vitro diagnostic devices for use in accordance with its functions, not as well as risks inherent to it.
76. For in vitro diagnostic devices with energy sources, and in vitro diagnostic devices that are connected to their energy sources, to: 76.1.in vitro diagnostic devices incorporating electronic programmable systems and software are developed, ensuring the system repeatability, reliability and relevance of in vitro diagnostic device;
76.2.in vitro diagnostic devices are designed and manufactured, eliminating the risks of creating electromagnetic perturbation which could impair the operation of other devices or equipment in the environment;
76.3.in vitro diagnostic devices are designed and manufactured, potentially reducing the risk of electric shock when it is used according to the manufacturer's instructions and in case of damage.
77. For in vitro diagnostic devices produced mechanical and thermal risk prevention, to: 77.1.in vitro diagnostic devices are designed and manufactured to protect the user against in vitro diagnostic devices created mechanical risks;
77.2.in vitro diagnostic devices maintain the stability of the intended operating conditions;
77.3.in vitro diagnostic devices to withstand the loads to which they are subject to the intended operating conditions, throughout the manufacturer for in vitro diagnostic devices during operation;
77.4. If the user's health or life is in any danger of in vitro diagnostic devices, damage the moving components, dismantling or leakage of substances, should be available for appropriate protective equipment;
77.5. protective equipment that contains in vitro diagnostic device, ensure that the intended protection, but adversely affected in vitro diagnostic device features and maintenance;
77.6. in the light of technical development, in vitro diagnostic devices are designed and manufactured, potentially reducing the risk posed by the in vitro diagnostic devices in vibration and noise, particularly at source (except if the vibration or noise is one of the in vitro diagnostic devices intended operations);
77.7. outlet and electrical, hydraulic and pneumatic energy supplies are developed and produced, eliminating any possible threat to the health and life of users;
77.8.in vitro diagnostic device components which come into contact with the user, excluding the parts or areas which are directly intended to supply heat or reach given temperatures and their surroundings are not sakarst to the temperature specified in the manufacturer's instruction when in vitro diagnostic device is used according to the manufacturer's instructions.
78. For in vitro diagnostic devices intended for use in non-professionals home conditions (hereinafter referred to as the self test devices), to: UR78.1.pa špārbaud devices are designed and manufactured to ensure that they operate according to the design, especially taking into account the patients ' level of training and skills, as well as providing for self-test devices and methods of use changes;
78.2. instructions for use of the information contained in the label would be easy to understand;
UR78.3.pa špārbaud devices are designed and manufactured to ensure the intended permanent patient in their ease of use, according to their functions in all stages of the procedure and reducing patient risk of errors in their use, as well as the interpretation of the results;
78.4. If the circumstances so require, devices for self-testing is a feature that enables the patient to check whether the self-test the device operates in accordance with its intended purpose.
79. the manufacturer for each in vitro diagnostic device adds information on its safe and proper use, including that information in the instructions for use or placing it on the label.
80. Information about safe and appropriate in vitro diagnostic device displayed on the device itself or, if necessary, on the trade package. If each unit individually wrap is not possible, this information refers to the overall packaging or instructions for use, which added a number of in vitro diagnostic devices.
81. the instructions for use in vitro diagnostic devices or packages that include one or more wrapped in vitro diagnostic devices. Instructions for use in vitro diagnostic device is not required when the purpose for which the in vitro diagnostic device is intended, not professional is understandable without it.
82. the information supplied by the manufacturer can also be a symbol with the condition that all of the symbols used and the color identification complies with the applicable standards. If the standard is not, symbols and colors used to indicate and explain the documentation supplied with the in vitro diagnostic device.
83.Uz in vitro diagnostic devices, labels or the in vitro diagnostic devices, taking into account the nature and quantity of ingredients, as well as the way in which put them into circulation may be considered as dangerous, places the hazard symbols set out in circulation of dangerous goods regulatory legislation. If the in vitro diagnostic devices or labels are not enough space to accommodate all necessary information, appropriate symbols placed partially on the label and in the instructions for use.
84.In vitro diagnostic device label: 84.1. manufacturer's name and address;
52.3. the name and address of the representative, if the in vitro diagnostic device manufactured outside the European Union, but it is expected to be put into circulation within the European Union;
84.3.in vitro diagnostic device characteristics and functions;
84.4. the word "sterile", if the in vitro diagnostic device is sterile, or the specific microbiological condition or level of purity;

84.5. batch number, preceded by the word ' lot ', or the serial number;
84.6. If necessary, the date to which the in vitro diagnostic device or part of it can be safely used without adversely affecting the in vitro diagnostic device features (including year, month, and, if necessary, also the day);
84.7. words ' for performance evaluation only ' if the in vitro diagnostic device intended for performance evaluation;
UR84.8.nor skin for use in vitro diagnosis only;
Special use, or 84.9. storage conditions;
84.10. any indication of action to take to in vitro diagnostic device be sure the patient, the user, third parties or the environment;
84.11. necessary warnings and precautions;
84.12. for devices for self-testing, an indication that the device is intended for self-testing.
85. If the in vitro diagnostic devices the purpose and functions of the Professional is not clear, not they indicate in the instructions for use and, if necessary, also on the label.
86.In vitro diagnostic devices and separate components (components) the manufacturer labels with batch or serial number. This number is assigned by the manufacturer, providing the manufacturer's renown, especially with regard to in vitro diagnostic devices detachable components.
87.In vitro diagnostic device instructions for use contents: 87.1. the provision in paragraph 84 (except 84.5 and 84.6.) this information;
UR87.2.nor skin for the composition of the reagent product or reactive concentrations of active ingredients or Kit, as well as, where appropriate, an indication that the in vitro diagnostic device contains other ingredients which might influence the measurement;
101.8. storage conditions, and an indication of shelf life following the first opening of the primary container, as well as reagent storage conditions and expected stability indicators;
87.4.in vitro diagnostic device characteristics and functions;
UR87.5.nor skin for the required special equipment, as well as information that helps the user to determine the suitability of the equipment in question for use in combination with the in vitro diagnostic device;
87.6. the type of specimen to be used for sample collection, pre-treatment and storage conditions, as well as guidance on the preparation of the patient;
87.7. detailed in vitro diagnostic device use procedures;
87.8. measurement procedures including: measuring method of 87.8.1;
UR87.8.2.nor skin for specific analytical operating parameters (e.g., sensitivity, accuracy, repeatability), restrictions on the application of specific techniques, as well as information about available reference measurement procedures and materials used;
87.8.3. after the measurement procedures or activities carried out before the in vitro diagnostic devices for use;
UR87.8.4.nor skin for the required special training;
54.6. mathematical methodology, in accordance with the analytical results of the calculation;
UR87.10.pas, by this measure, a change in in vitro diagnostic devices analytical activity;
87.11. information on internal quality control and tracking in vitro diagnostic device for calibration, including specific confirmatory procedures;
UR87.12.nor skin for the reference intervals for the quantities determined, including the appropriate reference population;
87.13. If an in vitro diagnostic device used in combination with another device, information about the parameters applied to in vitro diagnostic devices and equipment for the determination of safe and functional combination;
87.14. information that checks to see if the in vitro Diagnosta which device is properly installed and operated according to the safety requirements;
87.15. for in vitro diagnostic devices operating in high intense and frequency of calibration to ensure they operate properly and safely;
87.16. information on the management of waste resulting from the use of in vitro diagnostic device;
87.17. required indications in cases of damage to the protective, as well as information about the contamination of resterilization or liquidation;
87.18. If an in vitro diagnostic device is reusable, information on the procedures that provide in vitro diagnostic device reuse, including cleaning, disinfection, sterilization and reuse the packaging or clog you salvage, as well as an indication of the restriction on the number of reuses;
87.19. information on precautions to be taken in relation to magnetic fields, external electrical effects, electrostatic discharge, pressure and its changes, acceleration, sources of siltumaizdedz and other external conditions effects on in vitro diagnostic devices;
87.20. information on special precautions taken to avoid the risks of using specific or destroying the in vitro diagnostic devices;
87.21. If in vitro diagnostic device includes substances of human or animal origin, information about their potential infectious nature;
UR87.22.pa špārbaud of technical characteristics, including: the person concerned 87.22.1. without specialist knowledge easily understandable form of expression of the result;
87.22.2. information on patient behaviour in case of a positive, negative or indeterminate result;
UR87.22.3.nor skin for the error probability of the self test device shown in the results, as well as about the error;
87.22.4. General information necessary for the patient who uses the self-test the device, you can use it and understand the results obtained;
UR87.22.5.br warning, which clearly indicates that the patient is not recommended without consulting a physician for any medical activities;
87.22.6. information about it that if the self-test the device used to control the disease, the patient can perform the treatment only if he has the appropriate training;
UR87.23.nor skin for dialing instructions for use date and the date of the latest changes.
5. rights and obligations of the Agency. the Agency maintained 88 medical devices registry LATMED (LATMED) an electronic database that stores information about registered medical devices (including the provision of the information referred to in paragraph 97), manufacturers, distributors, as well as other information in accordance with these provisions, the Agency is obliged or entitled to acquire and store. LATMED manufactured in Latvia for the CE marking of medical devices labelled are the Member States of the European Union a common registry of medical devices (EUDAMED) independent EUDAMED.
89. The information that the Agency and the provision in paragraph 3 and 173 of that institution obtains the registration of medical devices, conformity assessment, distribution, operation and technical monitoring process is limited by the availability of information. This provision shall not affect the obligations with regard to mutual information (also the dissemination of warnings) with other European Union Member States competent authorities.
90. the Agency shall forthwith inform the other Member States of the European Union, the competent authorities of the Republic of Latvia of issued by notified bodies compliance solutions explored, envelope is suspended or withdrawn, and, upon request, of the receipt of the statement of conformity, issued or refused, as well as the vigilanc system activity exposed the essential requirements for medical devices does not satisfy.
91. the Agency for the treatment of LATMED is considered as the national information system managed at national information system within the meaning of the law.
92. the agency implementing the distribution of medical equipment and operational monitoring, as well as fulfilling other obligations laid down in these rules, in addition to other rights accorded in these provisions and obligations is entitled: 57.2. to control and monitor the circulation and the use of medical devices and related services in compliance with the requirements of this regulation;
92.2. to request and receive, free of charge, including a copy of the Declaration of conformity and the technical documentation a copy of all or part of the required circulation and the use of medical devices and related services safety evaluation;
92.3. to request and receive, free of charge, samples of medical devices from the manufacturer or distributor (if it is possible and does not conflict with the objectives of these provisions, the Agency after all necessary checks and actions it will be returned to the manufacturer or distributor respectively), and monitoring of medical devices or related services, or other type of laboratory expertise;
92.4. medical equipment technical supervision of quality and effectiveness in carrying out random control measurements, medical equipment production and sales sites to assess information communicated by the manufacturer and the reliability of the accounts;
92.5. develop and publish the distribution of medical devices to ensure the necessary monitoring programmes, guidelines, lists, instructions, information exchange, to recommend limited liability company "Latvian standards" of the European Union the list of the standard Adaptive;

57.5. these rules and other regulations in order to make the expertise of medical devices, to make decisions in relation to poor quality, wrong or wrongly labelled with the CE marking and unsafe medical devices manufacturing, trade, safe operating, technical rules and consumer rights violation cases;
92.7. establish a centralised electronic informational data base on incidents or potential incidents in accordance with the provisions of paragraph 194 and 195 to prevent patient quickly, users, and third-party health and life;
If the information accompanying the 92.8. the individual group medical devices (active and non-active implantable devices, devices that use human blood or human plasma derivatives, the devices manufactured utilizing animal tissue constituents and other high risk medical devices), to build and maintain an electronic database of information on such medical devices;
92.9. monitor every activity of the person who places on the market or use medical devices professional environment (medical and other institutions) or perform technical supervision of medical devices or maintenance (this also applies to participants in clinical trials and areas where clinical research).
6. registration and medical devices conformity assessment 93. Medical devices include the LATMED after registration at the Agency. The Agency shall assess the conformity of the medical device with the requirements of these provisions, as well as evaluate and include medical device LATMED of the type of device and its modifications, variants, which the technical and qualitative characteristics and usage of the cross are not significantly different.
94. to medical devices include LATMED, the Agency shall submit the rule 97.98.102., or documents referred to in paragraph 1, and the Agency shall check the documents in content and form meets the requirements of this regulation.
95. Medical devices that distribute limited and distributes specific therapeutic needs of the institutions, as well as medical equipment accessories Assistant devices, spare parts and components is entitled to register a single dissemination in accordance with these rules.
96. If registration or conformity assessment process does not demonstrate registration or conformity assessment of the conformity of the medical device medical device status and it is focused on improving health or promotion, it would be LATMED, but give it a health-enhancing goods status.
97. To register in the Republic of Latvia produce the medical devices, the applicant (manufacturer or his authorized representative) shall submit the following documents: 60.3. where application of the producer (legal and business) address, name, and the name of the medical device (in Latvian and in English), as well as any modification to the device variant names;
97.2. the applicant a copy of the certificate of registration (the original show);
60.5. medical device technical documentation, which includes information about medical devices lag model and all its modification options. If the medical device structure is simple and it's not 1 or 2 safety group medical device technical documentation may be designed as standard by the manufacturer or the manufacturer's specifications or the technical file with the section in which the medical device medical device must include the description, explanation, and the harvest methods, risk analysis, appropriate standards, development and results of the checks carried out, the pilot reports, label and instructions for use;
60.5. on a reasoned request by the Agency — the medical device packaging and labelling samples as well as samples of the medical device oriģināliesaiņ you;
97.5. The EC declaration of conformity, the manufacturer, and the other in place for early stage medical device conformity assessment carried out by proc fist who makes the notified body;
97.6. proof of warranty and how the service will be provided at the service, delivery, installation and maintenance of medical devices that are intended for single use;
97.7. ionizing radiation devices – license activities with ionizing radiation sources;
97.8. disinfectants-safety data sheet.
98. in addition to these regulations, paragraph 97, information in vitro diagnostic device manufacturers, whose location is in the Republic of Latvia and who, with their name the following devices into circulation, shall submit to the Agency all relevant information about: 98.1. the reagents, reagent products and calibration and control materials in the technological characteristics of common sense and analysis, as well as information about all the critical related changes (including withdrawal) and other relevant information;
98.2. with respect to this provision listed in annex 2 (A) and (B) the list of in vitro diagnostic devices and devices for self-testing, of data that points to the following medical devices, analytical parameters and – where appropriate – of diagnostic parameters, outputs, performance evaluation certificates and all the critical related changes (including withdrawal).
99. the Agency this rule 98. information referred to in paragraph 1 shall be notified to the EUDAMED.
100. The provisions referred to in paragraph 98, the requirements also apply to all new medical devices (also on the CAI active implantable medical devices and in vitro diagnostic devices), which are the last three years have not been available to the European Union market and innovative indicators, as well as that of the procedure involves analytical technology not continuously used in connection with the given mērlielum or other parameter on the European Union market in the last three years.
101. If the change type of samples or production technology and manufactured in the Republic of Latvia already registered medical devices or if put into circulation new devices of the type referred to in the version before it put into circulation or dissemination of the manufacturer shall provide the Agency with information under this provision and paragraph 97.98, and the Agency shall supplement the information contained in LATMED.
102. To register medical devices produced in third countries (countries that are not Member States of the European Union), the Agency shall submit the application in: where the 102.1. the manufacturer's name, address, as well as medical device name (in Latvian and in English) and all the medical device modification option name;
102.2. Authority official certifying that the authorized representative is entitled to register and distribute specific medical device in the Republic of Latvia;
102.3. the applicant, who is officially the manufacturer authorized representative in the Republic of Latvia, a copy of the registration certificate (showing original);
102.4. medical device technical documentation, which includes information about medical devices lag model and all its modification options (all relevant information, descriptions, explanations, suitable production techniques, risk analysis, appropriate standards, development and results of the trial reports, label and instructions for use);
102.5. on a reasoned request by the Agency — the medical device packaging and labelling samples as well as samples of the medical device oriģināliesaiņ you;
102.6. compliance statements for the device to be registered by the notified body;
UR102.7.re ģistrācij certificate copy (showing original) issued by the competent body responsible for the registration of medical devices in the country where the place of business of the manufacturer;
102.8. clinical trial data, safety data and other relevant information;
102.9. proof of warranty and how the service will be provided at the service, delivery, installation and maintenance of medical devices that are intended for single use;
102.10. proof of it, as will be provided vigilanc systems (including reporting to the Agency of any incident or situation that led to or could compromise or damage the patient, user, or third-party health or life);
102.11. documents necessary for registration of individual group Medi cīnisk devices (devices for ionizing radiation – license activities with ionizing radiation sources, disinfectants, safety data sheets);
102.12. If necessary, these rules and 98.2 98.1. information referred to in point.
103. All documents produced in the Republic of Latvia for the medical devices shall be submitted by the applicant in the language of the country.
104. If needed, the Agency may require certified translations of documents produced in third countries for medical devices.
105. in order to ensure the complete registration process, the Agency is entitled to request the additional information required-Central Committee of medical ethics, professional medical associations, the State Agency of medicines or other competent institutions applied for an opinion on the medical device.

106. If not submitted that rule 97, 98, 102 and 105. those documents or registration process, there is a need to clarify the important facts, the registration procedure shall be suspended and shall forward to the Agency a written request to the cold had 60 days submit the missing documents or to provide the overwhelming information don't. If the applicant needed information or missing documents not submitted within that period, the Agency shall adopt a decision to refuse registration.
107. LATMED medical device inserted, if the registration process is a certified medical device quality, safety, efficiency, and compliance status of the medical device, as well as, if necessary, properly certified warranty and service obligations, as well as the vigilanc system.
108. following the inclusion of the medical device LATMED the Agency shall issue a certificate of the jam on the medical device into the LATMED: 108.1. certificate for medical devices that are marked with the CE marking, the inclusion of the LATMED for an indeterminate period of time (the period of validity of the licence without restrictions);
108.2. certificate for medical devices into the LATMED for a period of between one and five years;
108.3. certificate for supply of medical devices and their accessories, components and spare parts into the LATMED for the period from the date of issue up to the delivery of the lump sum.
109. If the licence shall be issued for a period exceeding one year, register the licence holder shall submit an annual report on the Agency's vigilanc in the incident that became known, using specific medical device, and the measures taken to maintain a particular level or improve a joint medical device quality, safety and efficiency indicators according to the latest scientific and technical developments.
110. After certificate expiration date can be extended by performing a renewal. With a view to re-registering a medical device, not later than 60 days before the licence expires, submit an application for renewal and this 97.98.102. points, and mentioned in the document, as well as the previous registration period vigilanc report about the incident that became known, using specific medical device, and the measures taken to maintain a particular level or improve medical device quality, safety and efficiency indicators according to the latest scientific and technical developments.
111. The medical device register and re-register during the month following that rule 97, 98, 102, and 110.. submission of documents referred to in paragraph 1. The time required to obtain registration or Reregistration required need for additional information, including registration on time.
112. the decision on registration of the medical device or justified the refusal to register the medical device adopted by the Agency.
113. the Agency five days after the adoption of the decision shall inform the applicant about the medical device registration or renewal.
114. If the Agency takes a decision on refusal to register or reregister the medical devices, the Agency five days shall inform the applicant in writing, stating the reasons for the refusal. The refusal to register or reregister the medical device can be a challenge in the Ministry of health. The Ministry of health decision may appeal to the Court.
115. the Agency has the right to suspend or revoke the certificate of registration of the medical device, if: UR115.1.re ģistrācij documents are submitted to the contained false or misleading information;
115.2. medical device is dangerous and may result in danger to the user, the patient or a third party health or life;
115.3. failure to comply with medical device manufacturers or distributors of these contractual obligations and guarantee service or vigilanc system;
115.4. these provisions are not complied with, paragraph 109.
116. The medical device registration certificate annulment is the basis of specific medical device removal from circulation. The said licence suspension is the basis for a specific medical device distribution and sales suspension for a period of time until the day when the Agency shall adopt a decision on the renewal of the licence or its cancellation.
117. where a certificate of registration suspended or cancelled, the agency within five days of the decision in writing shall inform the authorisation holder and user. The owner of the certificate and the user is obliged within five days of receipt of the decision to transfer the Agency suspended or cancelled licence.
118. the information on the registration certificates for reversed the Agency publishes the newspaper "journal".
119. the decision on the suspension of the certificate of registration and cancellation may be challenged in the Ministry of health.
120. the Agency's receipt of the application by the manufacturer, which added to the doctor konsilij's opinion on the need for the medical device, can allow the Republic of Latvia to the individual medical devices that have not been mentioned in these provisions of the conformity assessment procedures and CE marking, and not for use in health care.
121. the conformity assessment of medical devices in the process of evaluating the response of the this regulation. 151. These provisions referred to by CAI medical devices before a conformity assessment carried out by the manufacturer of the application of this provision in annex 4 risk assessment and implement a risk management framework.
122. the conformity assessment of medical devices, to get a declaration of conformity, the manufacturer or his authorized representative is mutually agreed with the notified body of the conformity assessment procedures in accordance with Chapter 7 of these rules, any specific medical device is applicable, and of the time limits to which these compliance procedures performed. The notified body, duly justified grounds, require the necessary information and data to be able to take the test that provides the necessary conformity assessment proc is for a particular medical device fist. Decisions taken by the notified body for a particular medical device compliance shall be valid for not more than five years.
123. The notified body shall inform the Agency of the issued, suspended or withdrawn, rejected the statement of conformity.
124. The notified body may suspend, revoke or limit the match provided the bass in evidence if it is found that the manufacturer does not comply with the requirements referred to in these provisions.
125. the agency according to the competency assessed the notified body of the manufacturer and the appropriate conformity assessment procedures for accuracy and correct it and rightly labeled with the CE mark. If the CE marking is not appropriate, the Agency will immediately turn to the manufacturer and the notified body, or if non-compliance persists, shall immediately inform the European Commission and the other Member States of the European Union.
126. in order to facilitate new and modern medical technologies and informing the public about the medical devices that are marked with the CE marking, the free market opportunities public electronic information database, the Agency in accordance with the applicant's submissions and supplements the information on all marķētaj the CE marking medical devices, which are available in the Republic of Latvia. Content database at the same time also provides the vigilanc system efficiency and operational capacity of the patient, user and third parties protection against accidents that particularly apply to class IIb and III medical devices, active implantable medical devices, non-active implantable medical devices and materials mentioned in annex 1 of these regulations, (A), (B) list the list and checks by CAI medical devices, in vitro diagnostics and medical devices manufactured using the non-viable animal tissues make and origin of such tissue products.
127. This provision of the certificate referred to in paragraph 108 of the original kept by the licence holder. Always attach a copy of the certificate in the electronic check concluded medic device distribution or sales contracts. If that rule 108, paragraph the licence is lost, destroyed or otherwise becomes invalid, the certificate owner or the user is obliged within 10 days written notice to the Agency, the Agency shall issue the relevant certificates and duplicate of. The Agency, after the licence holder's written and justified the application of the evaluation is entitled to issue proof of the transfer of the licence to another person, allowing it to carry out the said licence medical device distribution. In this case, on the other side of the certificate shall be made on the certificate of the user of the mark, and this information is confirmed by the seal and signature of the person responsible.
7. Separate classes of medical devices and medical devices that are not manufactured in series production, registration and conformity assessment terms

128. By registering or exposing for conformity assessment used, refurbished or rebuilt, redesigned medical devices, in addition to this provision, 98.97 and 102 above documents and information, the applicant shall submit such proofs of conformity, which demonstrate that the medical device after the renewal, modification or conversion meets all quality, safety and efficacy requirements applicable to that type of device.
129. If medical devices are in class III, and it is not custom-made medical devices or medical device intended for clinical investigations, then assign to it the CE marking (given the right manufacturer medical device labelled with CE marking), the manufacturer shall comply with one of the following procedures: 129.1. This provision 5. the procedure referred to in the annex;
129.2. these rules 6 and 7 of the procedure referred to in the annex;
129.3. This provision 6 and 8 of the procedure referred to in the annex.
130. If a medical device class IIA and its not a custom-made medical device or a medical device intended for clinical investigations, then assign to it the CE marking, the manufacturer shall follow one of the following procedures: 130.1.7. these rules and procedures referred to in annex 9;
130.2. the rules 8 and 9 of the procedure referred to in annex a;
130.3.9 and 10 of these regulations. the procedure referred to in the annex;
130.4. in annex 5 of these provisions (with the exception of its paragraph 4) that procedure.
131. If the medical class IIb the device and it is not custom-made medical device or a medical device intended for clinical investigations, then assign to it the CE marking, the manufacturer shall follow one of the following procedures: 131.1. in annex 5 of these provisions (with the exception of its paragraph 4) that procedure;
131.2. these rules 6 and 7 of the procedure referred to in the annex;
131.3. This provision 6 and 8 of the procedure referred to in the annex;
131.4. This provision 6 and 10. the procedure referred to in the annex.
132. This provision 129.130.131, and in the cases referred to in paragraph the manufacturer shall draw up the EC declaration of conformity also.
133. If a medical device belongs to class I, and it is not made or intended for clinical investigations, then assign to it the CE marking the manufacturer shall follow the rules of the procedure referred to in annex 9, and draw up the EC declaration of conformity. In addition to that relating to sterilaj class I medical devices and medical devices with a measuring function, the manufacturer of comply with one of the following procedures: 133.1. the rules referred to in annex 8;
133.2. This provision 10. the procedures referred to in the annex;
133.3. This provision procedure referred to in annex 7.
134. with regard to medical devices made to order and clinical research design medical devices, the manufacturer shall follow that rule 11. procedure and referred to in the annex before placing the medical device on the circulation of these provisions shall be drawn up in annex 11, the notice and the statement of conformity with the essential requirements.
135. the CE marking shall be To highlight the active implantable devices, electronic check in the medic which are custom-made or intended for clinical investigations, the manufacturer shall draw up the EC declaration of conformity and the accompanying respect one of the following procedures: 135.1. This provision 12. the procedures referred to in the annex;
135.2. these rules 13 and 14 the procedure referred to in the annex;
135.3.13. these rules and procedures referred to in annex 15.
136. to put into circulation the individual made the active implantable medical device, the manufacturer before each such medical devices put into circulation of these provisions shall be drawn up in annex 16. that Declaration.
137. notified bodies decisions adopted in accordance with the provisions of annex 12 and 13, shall be valid to a date not exceeding five years. If the notified body application has been filed, the time limit may be extended for a period of five years.
138. with respect to all in vitro diagnostic devices (excluding this provision listed in annex 2 device) manufacturer to be labelled with the CE marking comply with this rule 17. Appendix (with the exception of its paragraph 6) that procedure.
139. All in vitro diagnostic devices (other than those intended for performance evaluation), the manufacturer shall draw up an EC declaration of conformity.
140. For all devices for self-testing (except 18. these provisions referred to in list B in annex glikometr) the manufacturer shall comply with one of the following procedures: 140.1. Annex 17 of these rules (including point 6) this proc is a fist;
140.2. the procedure set out in annex 2 to this regulation A list of devices;
140.3. the procedure set out in annex 2 to this regulation list B devices.
141. with regard to all these rules list A of annex 2 in vitro diagnostic devices (other than those intended for performance evaluation) the manufacturer so that they can be marked with the CE marking, follow either: 141.1. This provision 19. the procedures referred to in the annex;
141.2. This provision 18 and 20 of the procedures referred to in the annex.
142. with regard to all these rules list B of annex 2 in vitro diagnostic devices (other than those intended for performance evaluation) the manufacturer so that they can be marked with the CE marking, follow either: 142.1. This provision 19. the procedures referred to in the annex;
142.2. This provision 18. and the procedure set out in annex 21;
142.3. This 18 and 20 of the rules of procedure referred to in the annex.
143. with regard to performance evaluation of in vitro diagnostic devices the manufacturer will follow that rule 22. procedure and referred to in the annex before such devices put into circulation shall draw up the statement set out in that annex and statement of compliance with the essential requirements.
144. the manufacturer shall keep that rule 17, 18, 19, 20, 21 and 22. Declaration of conformity referred to in the annex, technical documentation, as well as the decisions, reports and certificates of in vitro diagnostic devices and, if necessary, to make them all available to the national authorities to verify five years since the last produced in vitro diagnostic device. If the manufacturer is not established in the European Union, the obligation to produce on request documents is his authorised representative.
145. the Agency and the decision of the notified body that it has taken in accordance with this rule 17, 18 and 19 of the annex relating to in vitro diagnostic devices, shall be valid to a date not exceeding five years. If the application has been filed, the time limit may be extended repeatedly for a period not exceeding five years.
146. the Agency shall, upon application by the manufacturer, which added to the doctor konsilij's opinion on the need for the medical device, the Republic of Latvia may allow the release of the single in vitro diagnostic device that is not made in these terms that the conformity assessment procedures and CE marking, and not for use in health care.
8. Special provisions relating to systems and procedure suites 147. Any natural or legal person who assembles, medical device CE marking within their intended purpose and within the limits of use specified by their manufacturers, in order to place them on the market as a system or procedure Pack, shall draw up and submit to the Agency a declaration stating that: 147.1. in accordance with the manufacturer's instructions have tested compatibility between medical devices;
147.2. a system or procedure Pack is packed and it is connected to the user the necessary information, which also includes a manual that meets the requirements of these regulations;
147.3. This provision and paragraph 147.2.147.1. these steps are applied to the appropriate internal control and verification methods.
148. If this provision in paragraph 147 above conditions are not met (for example, if a system or procedure Pack is a medical device for which no CE marking or where the chosen combination of medical devices do not match the original design), the system or procedure Pack shall be considered a medical device and as such subjected to a conformity assessment procedure in accordance with the provisions of Chapter 7.
149. all natural or legal persons to be placed on the circulation, is sterilizing this provision in paragraph 147 of the system or procedure Pack of your choice, follow one of these rules 7, 8, or 10. those conformity assessment procedures. The person concerned shall draw up and submit to the Agency a declaration stating that sterilisation has been carried out in accordance with the manufacturer's instructions.
150. This rule 147.148.149., and the products referred to in paragraph 1 shall not be marked with additional CE marking the manufacturer shall submit to the Agency, but all these rules 38, 39, 40, 41, 42, 43, 44, 45 and 46, paragraph information. 147. These provisions and declaration referred to in paragraph 149 of the store for five years.
9. Special provisions relating to medical devices manufactured by using non-viable to make the animal tissue, or tissue products originating

151. This chapter lays down the technical requirements for medical devices manufactured by using non-viable to make the animal tissue, or tissue origin of products (hereinafter referred to as tissue medical device), in relation to transmissible spongiform encephalopathy (TSE) risk of the patient or other people using tissue by the medical device design. The provisions of this chapter do not apply to tissue for medical devices, which are intended to come into contact with the human body or which are intended to come into contact with intact skin only.
152.151. These provisions shall apply to tissue for medical devices manufactured by using non-viable to make the bovine, ovine, caprine, deer, elk, mink and cats tissue.
153. tissue medical devices used in the manufacture of collagen, gelatin and fat meet at least the requirements as defined for use in food for human use.
154. tissue medical equipment the conformity assessment procedure involves compliance with the provisions of Chapter 2, with the essential requirements and conformity assessment of these provisions in paragraphs 129 and annex 4 technical requirements listed in the assessment.
155. The notified body in the conformity assessment process to evaluate the manufacturer's risk analysis and risk management strategy, including: 155.1. the information provided by the manufacturer;
UR155.2.dz īvniek of the tissues or derivatives (materials derived from animal tissues such as collagen, gelatine, and monoclonal antibody production process);
155.3. inactivation and elimination studies;
manufacturer of 155.4. raw materials, finished products and subcontractors of the origin of the substances;
155.5. need to control related to sourcing, as well as third party delivery.
156. The conformity assessment procedure, the evaluation of the risk analysis and risk management, announced the authorities take account of the TSE certificate of suitability issued by the European Directorate for the quality of medicines, if any such certificate is available in the case.
157. The notified body, in cooperation with the European Directorate for the quality of medicines, contact other participating Member States of the European Union opinion of the competent authorities of the risk analysis and risk management assessment and decisions concerning such tissues and derivatives, which are prescribed by the manufacturer for use in tissue of medical devices. This condition does not apply to tissue for medical devices that the used raw materials, TSE issued a certificate of conformity.
158. before the EC design-examination certificates or EC type-examination certificate issued by the notified body shall take account of all the provisions of the order referred to in paragraph 157 the opinions, if they received 12 weeks of a request to do so.
10. Medical devices and security group types 159. Medical devices are classified into the following security groups: 159.1.1 group-high technical risk possible equipment during use risk factors (electrical, radiation, mechanical and other types of strategic energy, biological, chemical, environmental and other factors or dosing systems) may directly and significantly affect the patient, user, or third-party health or endanger the lives of those persons (of these devices is to be classified as active medical devices) or damage to property;
159.2.2. Group-medium risk possible technical equipment, which operate using electrical or other energy, and thus are classified as active medical devices or devices with a measuring function;
159.3.3. Group-low technical risk possible equipment-all equipment not included in the first two groups.
160. the list of medical devices, in which certain medical devices (equipment) are listed by their breakdown by security groups listed in the annex to these provisions 23.
161. All 1 and 2 security groups and active medical devices medical devices cases accurately captures the special use of the device, and in Journal of accounting, to ensure traceability in the continuous monitoring system or vigilanc. Such records shall be provided in every medical institution or other institution where the use of such devices, regardless of whether the device is used according to medical or other indications.
162. When the information changes on a single security group, medical equipment medical equipment distributors and users provide the Agency with the information required for updating the registry for a particular medical device.
163.Ir this with the use of medical equipment related incident types: 163.1.1 type: accidents that result in the patient, user, or third party's death;
163.2.2. type incidents involving the use of the device is the result of an injury to the patient, user, or third-party health;
163.3.3. type-not when it is found in the device malfunctions or anomalies in the pamatparametro, which could occur due to damage to the patient, user, or third-party health or there is a possibility of an accident because the manufacturer, his authorized representative or distributor fails to comply with the guarantees provided by the system or not binding service, device maintenance measures, where appropriate, including qualified repairs, or an accident that has caused harm to the patient , user, or third party's property.
164. In the case of type 1 or 2 (if necessary-also a type 3): 164.1. medical devices the user immediately disconnect the device from the network and other devices;
164.2. the medical device user is doing everything necessary to medical device by not to use another person's, and the device clearly visible warning label shall be affixed;
164.3. immediately dialing this rule 165, paragraph signālziņojum of the accident.
165. The medical device user with its owner or holder within three days after the accident sent signālziņojum to the manufacturer or authorized representative and distributor for the medical device, as well as the Agency. The Agency followed the accident investigation process. If it finds significant facts in the situation further in the analysis, the accident may be added to signālziņojum. In the year you shall not signālziņojum stating: 165.1. medical device owner, address and other contact details;
165.2. the user of the medical device;
165.3. body in which the medical device is used;
165.4. medical device Distributor, the address and other contact details;
165.5. manufacturer or authorized person's name, address and other contact information;
165.6. medical device name;
165.7. medical device class, the security group type, category and number;
165.8. medical device model;
165.9. medical device serial number;
165.10. medical device components;
165.11. medical device used in computer programs;
165.12. similar accidents;
165.13. accident description;
165.14. accident;
165.15. medical devices current location.
11. the additional requirements for the 1 and 2 security groups for medical devices and security 2 166.1 group medical device may use the certified medical person, if the device is properly installed, is provided by the device manufacturer specific micro-characteristics, guaranteed power supply mode (if such a requirement is mentioned in the documentation of the medical device), sealed maintenance contract guaranteed a device manufacturer's certified use of the spare parts and the device is used according to its design.
167. Medical device installed and put into service the manufacturer or his authorized representative and adequate training in providing: 167.1. medical device supplied technical documentation for required environmental characteristics of the device and the transfer of medical records the device owner or holder;
167.2. medical device supplied technical documentation was requested by the sīt guaranteed power supply mode;
167.3. at least 30 hours of medical device user training, competence issued identity document;
167.4. medical device instructions and other documentation of the Latvian language and vigilanc's advocacy of a system user in relation to the specific medical device;
167.5. medical device metrological inspection function testing and calibration of the device when entering service, the requirements for technical documentation of the device;
167.6. medical device technical service within the warranty period and notified the manufacturer of the medical device resource period, if the medical device owner or holder choose such service resources.
168. The medical device owner or holder, entering the devices into operation, ensure that: UR168.1.nep ārprotam medical devices and its permanent location identification, as well as the institution developed recognition and coding system;

UR168.2.1.dro security group medical devices – liability insurance against the possible harm to the patient, user and third parties;
168.3. electrical safety of medical devices, the size of the main function and the nature of the inspection and metrological control;
168.4. proper medical device technical service within the warranty period and notified the manufacturer of the medical device, as well as the period of resources medical devices targeted technical service to the pēcresurs period;
168.5. appropriate qualified officers as of posting of the owner or the holder of the official contact person address issues of compliance with the requirements and cooperate with the Agency and other institutions;
information about the purchased 168.6.1. and 2. security group medical devices companies sent to the agency within 30 days after their purchase.
169. Medical device owner or keeper shall ensure that each 1 and 2 security group medical device registered in a separate journal, specifying information about: 169.1. notified the technical inspection authorities implement technical supervision, conservation of the date, the expert's name, supervisory investigator in the nosa Kuma and technical surveillance protocol number;
169.2. function of medical device interference due to improperly installed, maintained and operated for the medical device, as well as their nature and consequences;
169.3. disturbance detection function, as well as the name of the person who found the function;
169.4. cause of interference function;
169.5. function disturbance prevention measures;
169.6. maintenance and repairs date, company name and the name of the person who made the relevant work;
UR169.7.atk ārtot function in case of malfunction, check for type 3 incident signālziņojum to be sent in accordance with the provisions of the 163.164.165, and point.
170. Medical devices journal, accompanied by the maintenance and repair work carried out and the replacement parts list.
12. medical device use, operation and technical monitoring 171. Medical device use, operation and technical monitoring is a set of measures in the form of a regular control and monitoring measures, examination, or medical device use, operation and maintenance in accordance with these rules.
172. the Agency shall be entitled to make use of the medical devices and the monitoring of the ekpluatācij, in so far as it includes the distribution of supervisory functions in accordance with these terms, conditions and the distribution of the supervisory agency regulations.
173. technical supervision of medical devices is carried out by the institution in akred dad Latvian National Accreditation Bureau in accordance with the standard LVS EN ISO/IEC 17025:2000 "the competence of testing and calibration laboratories-General requirements" and is published by the Ministry of economy Announces you in the newspaper "Gazette" (hereinafter referred to as the technical supervisory authority). Technical supervision authority shall immediately notify the Agency of any violations of these rules of use, medical equipment operation and maintenance.
174. Custom-made medical devices into circulation if they comply with the rules set out in Chapter 2, with the essential requirements and the corresponding notice drawn up, while the IIA, IIb and class III medical devices is added to that rule 11. the notification referred to in the annex. All the documentation on these devices tation! manufacturer kept for at least five years.
175. The medical device intended for performance evaluation and are available for this purpose in laboratories or other institutions, are put into circulation, where they have made this rule 143. above procedure. All documentation of such devices shall be preserved for at least five years.
176. Medical devices that do not meet the requirements in these rules, you can play exhibitions and similar events, if there is a clear indication that the specific medical device can not be put into circulation because it does not meet the requirements in these rules.
177. If it is established that the CE marking has been affixed unduly or improperly, the manufacturer or his authorised representative shall be obliged to end the infringement. If the manufacturer irregularities not remedied within a period of 60 days, the Agency suspended a particular medical device registration certificate.
178. Where the agency finds that medical devices bearing the CE marking, as well as custom-made medical devices, even properly installed, maintained and used according to the design, may be harmful to the patient, the user or third-party health, it suspended a particular medical device registration certificate.
179. the Agency shall immediately inform the European Commission of any of the provisions of this paragraph 178 order suspended the registration certificate, setting out the reasons for its decision and whether non-compliance with the requirements contained in these provisions is linked to essential requirements: 179.1. defaults;
179.2. incorrect application of the standards (if it is claimed that the standards have been applied);
179.3. shortcomings in the standards.
180. If a non-compliant with the essential requirements of the medical device CE marking, the Agency suspended the medical device registration certificate and shall inform the European Commission and the other Member States of the European Union.
181. the users of medical devices shall report to the Agency on accidents, and the Agency recorded and assessed all the information about the incidents, including: UR181.1.par any one parameter of the medical device or malfunction or deterioration, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or health risks;
UR181.2.par any technical or medical reason in relation to the characteristics or performance of a device, which is of the same type by the manufacturer of the medical device regularly removed from circulation due to 181.1. these provisions referred to in the reasons.
182. the Agency shall inform the relevant medical device manufacturer or its authorised representative for all cases not referred to in paragraph 181 of these provisions, unless such information is already provided in these rules, the 164.163. and in paragraph 165.
183. After accident assessment, which, if possible, be carried out with the producer, the Agency shall, without prejudice to this provision and paragraph 180 179., of the accident shall immediately inform the European Commission and the other Member States of the European Union.
184. the Agency shall submit a reasoned request to the European Commission to take measures, if not ciešamo the classification rules of the application requires a decision about: 184.1. specific medical device or category of devices;
184.2.to if a medical device or family of devices should be in another class, by way of derogation from the provisions of the classification;
184.3.to, or, by way of derogation from the procedure set for the assessment of conformity of the medical device or the offered device compliance must be determined by the family, through the application of only one of the conformity assessment procedures.
UR185.1.dro security group, medical devices, active medical devices, active implantable medical devices and active implantable devices electronic check in the medic and the materials used in the treatment of persons certified in accordance with the estimated medical institution or other institution, if that person gets treatment competence certificate after the corresponding special papildapmācīb in specific active implantable medical device or 1. security groups and use the medical device if the authority is provided by specially trained technical staff service services medical devices for proper maintenance.
UR186.1.dro security groups, active medical devices medical devices, active and non active implantable medical devices and materials, as well as invasive medical devices correct use provides, regardless of whether the device is in use by the medical institution or other institution, and whether or not it is used only in accordance with medical indications or other reasons.
187. Each security group 1 medical devices and active use of the medical devices and active implantable medical devices and implantable non active medical devices or use of the material accurately records the use of the medical device, procedure, or manipulation of the test log book regardless of the device used a medical institution or other institution, and whether or not they are used in accordance with medical indications or other reasons to be able to provide continuous surveillance of traceability or vigilanc systems.
13. Vigilanc system and a continuous technical monitoring

188. Vigilanc system is laid down in these provisions set of requirements, followed by medical equipment manufacturers, their authorised representatives, distributors, owners, proprietors and holders and providing reporting and evaluation reports to the Agency's involvement in the activities of any medical device related incidents or potential incidents that have caused or could cause harm to the patient, user, or third-party health or risk to life.
189. Vigilanc system of measures to ensure the traceability of the medical device, ranging from design to use for the end of the term, but in the case of implantable devices, to the implant.
190. Vigilanc system procedure is unified and applied to all Medi cīniskaj devices.
191. the aim of the Vigilanc system using medical devices user accident reporting system in all the Member States of the European Union, to provide Member States the opportunity to simultaneously identify and use existing inadequate medical device model and serial and prevent the accident from happening again.
192. Medical device owner or the holder of a medical device operating time shall take into account the requirements of this regulation to be respected throughout the manufacturer's medical device specified in the use of resources and also after the end of that period, if the continuation of the operation of the medical device is duly justified.
193. According to the manufacturer's medical device electrical safety specified group all authority registered 1 and 2 security groups for medical devices at least once a year to ensure electrical safety checks carried out by the accredited notified technical evaluation authority, unless the medical device manufacturer has indicated otherwise.
194. Current electrical safety test report number, the technical opinion of the supervisory authority for the six month period and information on the next check time medical device owner or holder electronically transmit to the Agency. This provision may not apply to bodies 1 and 2 security groups the number of devices 10.195. Medical devices in case of damage to its possessor or holder by following the requirements of this regulation, have the right to require that the manufacturer or his authorised representative shall immediately deliver the certified spare parts and necessary steps to 1 and 2, safety of the medical device group (if it is technically complex and unique high-tech medical device) idle does not exceed 21 days taking into account that: 2.195.1.1., and security groups in case of damage of the device is only allowed the manufacturer's certified block replacement spare parts, replacement parts 1 and 2 security groups medical devices journal section in question;
UR195.2.nav the manufacturer of any permitted unauthorized block spare parts repair and reuse of medical device.
196. the function of the medical equipment is tested and evaluated compliance with the rules referred to in paragraph 173 institutions taking into account medical device working hours or the number of the procedures and medical devices from the izgat age of bags the moment or period of operation. Compliance testing and evaluation to be carried out at least: 196.1. every two years, if the device is operated for less than four years;
196.2. once a year, if the device is operated for four to seven years;
196.3. twice a year, if the device is operated for more than seven years ago (or manufacturer's device clearly identified resource) and if the technical service agreements concluded confirms that sub-paragraph 168.4. conditions are properly fulfilled.
197. Medical device owner or keeper provides extraordinary medical device electrical safety and function of the metrological verification, compliance testing and calibration after repair or device manufacturer or authorised by upgrading your device, subject to the requirements of this regulation for this rule in paragraph 195 of the maximum allowable downtime.
198. the possessor or medical device holder provides the specific medical devices and medical devices for the training of officials responsible for the desired quantity and quality.
199. the technical supervisory authority, implementing the medical devices operation monitoring of the institutions that provide services to the medical device, used at random without consideration made accidental medical device safety and compliance testing of devices function of quality control tests and measurements.
200. the possessor of a medical device or medical device to the holder after repair or doubt in cases of uncertainty regarding its safe operation is guaranteed the right to invite experts device function parameter matching pārtestēšan.
201. The continuous monitoring system of vigilanc or agency after the accident signālziņojum from the possessor of the medical device or the holder: UR201.1.re ģistr accident signālziņojum;
201.2. suggests or makes a particular category of accidents according to the temporary measures for accidents involving medical device: 201.2.1. limit the specific medical device or medical equipment all this model use;
201.2.2. completely banning specific medical device or medical equipment all this model use;
201.2.3. suspending a specific medical device registration certificate;
201.3. controls how the accident investigation;
UR201.4.sa taken from the manufacturer's initial report of the accident, the accident investigation required interim reports and final report of the accident;
UR201.5.re ģistr all investigate the accident report;
201.6. in consultation with the manufacturer, shall decide on any necessary corrective actions;
201.7. If the investigation gives the appropriate approval for the necessary corrective actions, informed of the accident in the other Member States of the European Union, the competent authorities and the European Commission;
UR201.8.kad accident investigation is completed and the final decision has been taken or proposed, as well as the necessary measures, the Agency terminated the case and inform the person concerned of the results of the investigation.
202. A medical device manufacturer is fully responsible for the necessary investigative actions, the implementation of accident situations regardless of not opening and investigation of ma space providing weather graphics from the report the manufacturer's information of the moment: 202.1. manufacturer's initial report on the accident by the medical devices agency sent 10 days;
202.2. manufacturer's report on potential accidents with medical device agency dispatched not later than 30 days.
203. After the completion of the investigation of the accident by the manufacturer ensure years of investigation you opinion of the operations, and is entitled to receive reasonable explanations from the Agency due to the actions (especially if the medical device is removed from circulation).
204. the completion of the investigation, the manufacturer shall draw up and transmit the final report of the investigation within the Agency. The accident investigation final report is notified you on the results obtained and the necessary concerted action.
205. the manufacturer shall ensure that the procedures referred to in this chapter shall apply to his authorised agents or other persons who are jointly responsible for the release of the medical device and the maintenance and use of the vigilanc system.
206. the possessor of the medical device or the holder after the accident signālziņojum accident dispatch of investigation in cooperation with the medical device manufacturer or his authorised representative shall continue accident investigations, evidence obtained periodically inform the Agency and provide the agencies or other experts, the manufacturer and the notified body free access to the above device, as well as procurement, accounting, insurance, training, appraisal, instruction and technical supervision.
207. If the medical device owner or holder is in doubt, or if he does not agree with the manufacturer's investigation of the accident, he has the right to invite independent experts or to request an accidental medical device or a product of technical expertise again.
208. the Agency shall establish and publish guidelines on vigilanc systems, proceed frame and activities, and recommendations.
209. when preparing the documents referred to in this chapter and their projects or deciding on the distribution of documents to the applicable technical way to observe confidentiality. Choosing technical means for the notification of the decision and document delivery, with priority given to the service directly to the person concerned (in particular, it refers to the user of the device or treatment facility management).

210. If one of the Member States of the European Union in the framework of the vigilanc system puts the Agency accident report on a specific model and serial medical device malfunctions or accidents that caused injury to the patient's health or caused the death of a patient, the Agency shall forthwith notify the holder of that medical device or holders in the Republic of Latvia concerning the decision adopted in connection with the use of that device. In an emergency, if there is a serious threat to public health, the Agency warned the public, via the media.
211. the Agency shall immediately communicate the decision to place medical devices on the ERS, or holders, whose possession or holding a certain model for medical devices from new discovered so far unconscious patient health or life hazard risks or proven model mismatch younger or change the requirements of the standards.
212. the manufacturer after the possessor or user message may not be sent to the Agency at the start of the accident report if: 212.1. user before use medical device start-up failure and found they immediately removed;
212.2. manufacturer has credible information that the incident is not directly related to medical device use, but the patient's health changes in volume are associated with clinical progress. In this case, the treatment of the person and the producer's view of the accident, its nature and the outcome should be the same;
212.3. accident cause is clearly established by the manufacturer of the device in the storage or use, and deadlines are clearly indicated in the documentation accompanying the device electronic check medic;
212.4. accident prevent using functional signalling device medical device or other protective device, which was made according to the standards, and therefore do not allow the patient to life risk;
212.5. medical device featuring a very low number of accidents. This applies particularly to the potential accidents if all risk factors have been identified, assessed and identified as acceptable in their tiny number;
upcoming and expected 212.6. adverse reactions noted in the medical device label and in the instructions for use, specifying the functional and numerical expression, which includes the individual patient's potential benefits and potential health hazards in the comparison by using the specific medical device;
212.7. adverse reactions and risk analysis of identification records are available to the manufacturer's technical file. The manufacturer shall not be entitled to claim that it had anticipated and announced to the user risk assessment, if the user does not have a corresponding notation;
212.8. the incident occurred at a time when the producer has already received a warning by the agency that contains certain requirements, and the manufacturer will act in accordance with them.
213. the Agency shall ensure the monitoring of the distribution of medical devices and vigilanc systems of information protection of data according to the data of natural persons protection law, commercial law and the freedom of Information Act requirements, as far as European Union law for medical devices does not provide otherwise.
14. Closing questions 214. Starting with the 9 July 2005, medical devices monitoring and control information exchanged pursuant to the standard LVS EN ISO 15225:2000 "global medical devices nomenclature, principles of construction and building" and the exchange of information, technical specifications of EN ISO/TS 20225:2001 (E) specification of the "stock exchange" for the purpose of management. The exchange of information with the European Commission and the Member States of the European Union, the competent authorities shall use uniform market surveillance documents and reports in English.
215. the registration certificate of medical devices issued up to the effective date of the rules shall be valid until the expiry of their issue, unless the agency determines it does not comply with the requirements of these regulations. The Agency may assess up to 2006 April 1 and, if it is established that the medical device meets the requirements of these provisions, and issue the renewal carried out a new card or withdraw an existing certificate.
216. by 1 January 2007 the circulation can be placed on a medical device, which is an integral part of sound human blood or plasma and which do not meet the requirements of this regulation. The following medical devices until 1 January 2009 may realize and put into service.
217. before 1 April 2004, the rules referred to in paragraph 151 medical devices issued the EC design-examination certificate or an EC type-examination certificate owners please notify authority additional EC design-examination certificate or an EC type-examination certificate, demonstrating compliance with the medical devices concerned rules referred to in annex 4 technical requirements.
218. Be declared unenforceable: 218.1. Cabinet of Ministers on 6 March 2001 a Regulation No 100 "medical equipment and medical product registration, marketing and distribution arrangements";
218.2. Cabinet of Ministers of 19 February 2002, the Regulation No 78 "medical equipment and medical product operating and technical supervision order.
Informative reference to European Union directives, the regulations include provisions resulting from: 1) of the Council of 20 June 1990 directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices;
2) Council of 14 June 1993 of Directive 93/42/EEC concerning medical devices;
3) Council of 22 July 1993 of Directive 93/68/EEC amending Directive 87/404/EEC (simple pressure vessels), 88/378/EEC (safety of toys), 89/106/EEC (construction products), 89/336/EEC (electromagnetic compatibility), 89/392/EEC (machinery), 89/686/EEC (personal protective equipment), 90/384/EEC (non-automatic weighing instruments), 90/385/EEC (active implantable medical devices), 90/396/EEC (appliances burning gaseous fuels) , 91/263/EEC (telecommunications terminal equipment), 92/42/EEC (new water heaters that heat with liquid or gaseous fuels) and 73/23/EEC (electrical equipment designed for use within certain voltage limits);
4) Council of 27 October 1998 Directive 98/79/EC on in vitro diagnostic medical devices;
5) of the European Parliament and of the Council of 16 November 2000 Directive 2000/70/EC amending Council Directive 93/42/EEC on medical devices incorporating stable derivates of human blood or human plasma;
6) the European Parliament and of the Council of 7 December 2001, Directive 2001/104/EC amending Council Directive 93/42/EEC concerning medical devices;
7) Commission of 3 February 2003 Directive 2003/12/EC on the breast implant reclassification Directive 93/42/EEC concerning medical devices;
8) Commission of 23 April 2003 of Directive 2003/32/EC establishing the detailed technical parameters related to the requirements laid down in Council Directive 93/42/EEC concerning medical devices manufactured utilising tissues of animal origin.
Prime Minister a. Halloween Health Minister g. Smith Editorial Note: rules shall enter into force on 19 august 2005.
 
1. Cabinet of Ministers of 2 august 2005 Regulations No 581 classification criteria 1. General questions 1. service life of the medical device is divided into short-term (normally intended for continuous use, which lasts less than 60 minutes), short term (normally intended for continuous use for not more than 30 days) and long term (generally intended for continuous use for more than 30 days).
2. with respect to medical devices, which in full or in part, penetrates inside the body through a body orifice or a surface (invasive medical devices), the body means any body opening, including the outer surface of the eyeball, or any artificial temporary open (such as stoma).
3. Surgically invasive medical device Cabinet 2 august 2005 No. 581 of the provisions "of the registration of medical devices, conformity assessment, distribution, operation and technical monitoring procedures" (hereinafter the rules) in the Interventional medical device which, in whole or in part, penetrates inside the body through the surface of the body with the help of surgical operations.
4. Arimplantējam device shall mean any medical device that is intended for use at least one of the following purposes: 4.1 completely enter the human body;
4.2. to replace an epithelial surface or the surface of the Court, intervene surgically, which is intended to remain in place after the procedure.
5. Reusable surgical instrument is a surgical instrument that is intended to be used for cutting, drilling, sawing, scratching, scraping, stapling, pull-in, spraušan or similar procedures, without connection to other active medical device and which the proper procedures may be reused under the terms.

6. active medical device means any medical device which is powered by electricity or other forms of energy (except for energy, which leads directly to the human body or gravity) that works by converting this energy. Medical devices designed to manage energy, substances or other elements between an active medical device and the patient without causing significant changes are not considered active medical devices.
7. active therapeutical device means any active medical device which is used alone or in combination with other medical devices, to support, modify, replace or restore biological functions or structures, treating or alleviating illness, injury or handicap.
8. active diagnostic device means any active medical device which is used alone or in combination with other medical devices, to supply information to lag the physiological States of health, illness or congenital malformations for the detection, diagnosis, monitoring or treatment.
9. the meaning of the provisions of the Central circulatory system are the following: arteria-pulmonal vein, aorta, ascenden coronaria arteria is a commune of carota, arteri, arteri-, of the extern carota arteri carota, the intern of the cerebrals of arteria, trunc, of brachicephalic vena CORDIS, the vena cava of pulmonal, ven, ven Cave of the superior inferior.
10. Under the terms of the central nervous system are the brain, meninges and spinal cord.
2. Execution conditions 11. apply for classification, taking into account the medical device functions.
12. If a medical device is intended for use in combination with another medical device, apply the classification of each medical device separately. Accessories are to be classified separately from the device, together with accessories used.
13. Software, which medical drives a device or influences the use of a device, falls automatically in the same class belongs to a particular medical device.
14. If a medical device is intended to be used solely or principally in a specific part of the body, it is classified on the basis of the most critical specified use.
15. If the same medical device subject to conditions, based on the performance specified for the device by the manufacturer, the stricter conditions in the higher classification.
3. Classifications 3.1 non-invasive medical device 16. All non-invasive medical devices are in class I if they are applicable to any one of the following points in this subdivision.
17. all non-invasive medical device intended to be used to manage or store blood, body liquids or tissues, liquids or gases it for later delivery to infuzēšan, or entering the body are in class IIA, unless (in all other cases they are in class I): 17.1. they can connect with any of the IIA or a higher class of active medical devices;
17.2. the intended use to store or manage the blood or other body liquids or for storing organs, parts of organs or body tissues.
18. all non-invasive medical device intended to be used to modify the blood, other body liquids or other liquids intended for body infuzēšan of the chemical or biological composition, class IIb (if one treatment does not include gas or heat, filtration, centrifugation or exchanges – in which case they are in class IIA).
19. All non-invasive medical devices which come into contact with injured skin: 19.1. are in class I if they are intended for use as a mechanical barrier, for compression or for absorption of exudates;
19.2. are in class IIb if they are intended for use primarily to hurt you hurt the DermIS and if they treat only secondary;
19.3. in all other cases, class IIA, including at schools, medic, which is mainly intended to be used to treat injuries the micro.
3.2 invasive medical devices 20. all to body orifices invasive medical devices (other than surgically invasive devices and devices that are not intended for connection to an active medical device): 20.1. are in class I if they are intended for transient use;
20.2. in class IIA if they are intended for short-term use (except when they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity, in which case they are in class I devices);
20.3. are in class IIb if they are intended for long term use (except when they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity and are not possible by absorption in the mucous membranes, in which case they are in class III devices).
21. all invasive medical device intended for entering body orifices (other than surgically invasive devices connected to a class II or higher for active medical device), the present IIA the ses.
22. All surgically invasive medical devices intended for transient use are in class IIA unless they are: 22.1. special designed to diagnose, monitor or correct a defect of the heart or of the Central circulatory system through direct contact with these parts of the body, in which case they are in class III;
UR22.2.atk ārtot to use surgical instruments, in which case they are Iklas devices;
22.3. intended use of ionizing radiation, in this case they are class IIb devices;
22.4. for biological effect or to be wholly or for the absorption-in which case they are in class IIb devices;
22.5. for medicinal products a delivery system, if this is done in a potentially dangerous way, depending on the method, in which case they are in class IIb devices.
23. All surgically invasive medical devices intended for short-term use are in class IIA unless they are intended: UR23.1.lai particular, diagnose, monitor or correct a defect of the heart or of the Central circulatory system through direct contact with these parts of the body, in which case they are in class III;
UR23.2.lai specifically used in direct contact with the central nervous system, in which case they are in class III;
UR23.3.lai use of ionizing radiation, in this case they are class IIb devices;
UR23.4.lai use a biological effect or to be wholly or mainly absorbed, in which case they are in class IIb devices;
14.6. the chemical change in the body (except where medical devices are placed in the teeth) or to administer medicines, in this case they are class IIb devices.
24. all implantable medical devices and long-term surgically invasive medical devices are in class IIb, unless they are intended: UR24.1.lai placed in teeth,-in this case they are in class III;
UR24.2.lai use in direct contact with the heart, the Central circulatory system or the central nervous system, in which case they are in class III;
24.3. biological effect or to be wholly or absorbēš the nai, in which case they are in class III;
15.2. the chemical change in the body (except where medical devices are placed in the teeth) or to administer medicines, in which case they are in class III devices.
3.3 active medical devices culpably violate applicable applicable to 25. All active therapeutic medical devices intended for entering or Exchange energy are in class IIA (unless the parameters are such that entering or exchange of energy from the human body or is potentially hazardous, taking into account the energy, intensity and type of place – in this case they are in class IIb devices).
26. All active medical devices intended for class IIb active therapeutic medical devices of control or management or medical devices for the direct influence, are in class IIb.
27. Diagnostics for active medical device in class IIA if: s UR27.1.taj for use the energy absorbed by the human body (excluding medical devices used to illuminate the patient's body, in the visible spectrum);
27.2. they are intended to represent the distribution of pharmaceutical substances in vitro;
27.3. for vital physiological process for the direct diagnosis or monitoring (unless they are specifically intended for monitoring of vital physiological parameters, where the nature of variations is such that it is at risk due to immediate patient, such as heart rate, respiratory or central nervous system disorders, at the bass – in which case they are in class IIb devices).
28. Active medical devices intended to emit ionizing radiation and used in diagnosis and therapeutic intervention radiology, including medical devices, controlled or monitored by such medical devices or which directly influence their activities, are in class IIb.

29. All active medical devices intended to enter or receive medicines, body liquids or other substances to or from the human body are in class IIA (unless that is potentially hazardous, taking into account the characteristics of the substance used, specific body parts and their use, in this case they are in class IIb devices).
30. all other active medical devices, which are not mentioned in this section, are in class I.
3.4. special conditions 31. All the medical devices that form an integral part, a substance which is used by itself, is considered to be a medicinal product and may act on the man, helping device to achieve the desired results, are in class III. All medical devices, which are an integral part of the human blood derivative, belongs to IIIklas.
32. all medical devices used for contraception or sexually transmitted diseases to stop class IIb (unless they are implantable or long term invasive devices, in this case they are IIIklas devices).
33. all medical devices, specifically designed to disinfect, brushed, tumbled or, if appropriate, hydrating contact lenses are in class IIb.
34. all medical devices intended specifically for other disinfection of medical devices are in class IIA. This condition does not apply to products intended to physically clean the other medical devices (excluding contact lenses).
35. All non-invasive medical devices intended specifically for x-ray beam diagnostics acquisitions, class IIA.
36. all medical devices that are made from animal tissues or products derived from animal tissue, are in class III (except where such medical devices are intended to come into contact with intact skin only).
37. the blood bags are in class IIb.
38. Breast implants are in class III.
Health Minister g. Smith annex 2 Cabinet 2 august 2005 Regulations No 581 In vitro diagnostic device classification (A) list 1. Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: ABO system, Rhesus (C, c, D, E, e) anti-Kell.
2. Reagents and reagent products, including related calibrators and control materials, for determining the confirmed and quantified from the samples obtained from human hand marker for HIV infection (HIV 1 and 2), HTLV I and II, hepatitis B, C and d. list B 3. Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: anti-Duffy and anti-Kidd.
4. Reagents and reagent products, including related calibrators and control materials, for the occasional antieritrocitār antibody determination.
5. Reagents and reagent products, including related calibrators and control materials, for determining and quantified from human samples obtained the following congenital infections: rubella, toxoplasmosis.
6. Reagents and reagent products, including related calibrators and control materials, for diagnosing the following hereditary disease: phenylketonuria.
7. Reagents and reagent products, including related calibrators and the contra les materials, for determining the following human infections: Cytomegalovirus, chlamydia.
8. Reagents and reagent products, including related calibrators and control materials, for determining the following HLA tissue groups: DR, A, B. 9. Reagents and reagent products, including related calibrators and control materials, for determining the following tumoral marker: PSA.
10. Reagents and reagent products, including related calibrators, control materials and software, designed specifically for risk assessment of trisomy 21.
11. Medical Self-diagnosis device – the device determine the quantity of sugar in the blood-horse and its related calibrators and control materials.
Health Minister g. Smith 3. Cabinet of Ministers of 2 august 2005 Regulations No 581 CE conformity mark 1. The CE conformity marking consists of the initials ' CE ' in the following form: If the marking is reduced or enlarged, followed this annex paragraph 1 specified in the graphical proportions in the picture.
3. The various components of the CE marking is based on the vertical direction, and must not be less than 5 mm. This minimum dimension may be waived for small medical devices.
Health Minister g. Smith 4. Cabinet of Ministers of 2 august 2005 Regulations No 581 Risk analysis and risk management General 1 question 1. on the basis of special medical equipment to overall risk analysis and risk management strategy, the manufacturer, based on the decision of the Cabinet of Ministers 2 august 2005 No. 581 of the provisions "of the registration of medical devices, conformity assessment, distribution, operation and technical monitoring procedures" (hereinafter rules) 151. 152.153., and of the animals referred to in the use of tissues or derivatives (detectable in animal species and tissues) taking into account the expected clinical benefit, potential residual risk and suitable alternatives.
2. Procedure 2.1. purpose of evaluation procedures and tasks, 2. to ensure the patient and the user a high level of protection, and medical device manufacturers, which use rules 151 and 152, 153. referred to animal tissues or derivatives, implement appropriate and well documented risk analysis and risk management strategy in respect of all transmissible spongiform encephalopathies (hereinafter TSE) aspects. Having regard to the intended use of the medical device and benefit from it, the manufacturer identifies the hazards associated with such derivatives, tissues and develop documentation on the measures taken by the transmission risk reduction and considered risk acceptability limits indicated for the medical devices incorporating such tissues or derivatives.
3. safety of the medical device in relation to the potential transmission of the transmissible agent is dependent on this item 2.2., 2.3., 2.4., 2.5., 2.6, 2.7 and 2.8. bottom section. these factors, which the manufacturer analyse, assess and manage.
4. in paragraph 3 of this annex, the said measures shall determine the safe use of the medical device. These measures can be divided into the following groups: 4.1 apply for raw materials (tissues or derivatives) select, subject to further processing, which is considered appropriate in the context of their potential contamination with transmissible agents (2.2, 2.3 and 2.4. subchapter);
4.2. the application of a production process to remove or inactivate transmissible agents tested in the tissues or derivatives in the place of origin (2.5-subchapter).
5. in paragraph 4 of this annex, these measures take into account the joint medical device description and its dedicated functions (2.6, 2.7 and 2.8. subchapter).
6. The risk analysis and risk management strategy, the manufacturer shall give due consideration to the opinion of the Scientific Committee and, if necessary, the opinion of the Committee for proprietary medicinal products, which have been published in the Official Gazette of the references in the official journal of the European Union.
2.2. animals as raw material 7. excludes producer risk the use of animals, including the use of animals that died or forcibly slaughtered or suspected about the transmission of TSEs.
8. A new and healthy animals are considered risk factors for sam knowledgeable.
2.3. the geographical origin 9. In assessing the risk of the country of origin, use the geographical risk of LSE (ĢLR) to the classification of the Member States of the European Union in accordance with the LSE status of the European Parliament and of the Council (EC) may 22, 2001, in Regulation No 999/2001 (hereinafter Regulation No 999/2001), which establishes certain trans misīv spongiform encephalopathy prevention, control and eradication.
10. ĢLR is a quality indicator in the country according to the period in respect of one or more with the LSE as its clinical, preclinical infected beef being the probability. If the infected animal's existence is confirmed, ĢLR points to a level of infection in accordance with the following table: one or more ĢLR with the LSE agent preclinical or clinical infected beef being the geographical region or country I highly unlikely very unlikely, but II is not turned off, but there is no Reliable III approved or approved below the level approved for the highest level IV 11. Some factors affecting the LSE the geographical risk of infection associated with the raw materials the use of tissues or derivatives from individual countries. Such factors are certainly the international animal health code article 2.3.13.2.
2.4. Raw tissue types 12. the manufacturer shall take into account the hazard classification, associated with different tissue types of raw materials. Animal tissue of origin test and inspect the cut * a veterinarian. Animal carcasses valued according to validity for human consumption.
13. the manufacturer shall ensure that, at the time of slaughter, there would be no risk of cross contamination.
14. the manufacturer does not determine the origin of animal tissues or derivatives, which are classified as potentially high TSE contamination risks, provided that the determination of the origin of the material is necessary in exceptional circumstances, taking into account the substantial benefits for the patient and the lack of alternative raw materials in tissues.

15. with regard to the matters discussed in this subdivision, where necessary, of the European Parliament and of the Council of 3 October 2002 Regulation (EC) No 1774/2002 (hereinafter Regulation No 1774/2002) which provides hygiene requirements for animal by-products not intended for human consumption.
16. in the case of ovine and caprine animals, the manufacturer shall take account that: 16.1. classification of contamination of tissues in ovine and caprine animals has been developed on the basis of the actual knowledge of the transmissible agent in tissue and organism subtitles fluids from naturally infected sheep and goats with clinical scrapie. The Scientific Steering Committee of 22-23 July table is included in the "sheep breeding and genotipēšan policy" (referred to in annex 2 of the opinion). This table has been updated following the Scientific Steering Committee in December 2001 (adopted 2002 10-11 January) opinion on the prevalence of TSE contamination of ruminant tissues;
16.2. the classification will be reviewed in the light of new scientific information (using the appropriate Scientific Committee, the opinion of the Committee for proprietary medicinal products and the European Commission of measures governing the TSE risk material injurious use). The opinion of the relevant document or reference report is published in the Official Gazette of the official journal of the European Union and is listed in the European Commission decision.
17. with regard to cattle producers take into account Regulation No 999/2001 list of special risk materials, which are considered as potentially high TSE infective.
2.5. inactivation of transmissible agents and separation for 18 medical devices which cannot withstand an inactivation or elimination process without significant damage, the manufacturer, based on the verification of origin.
19. If, in the case of other medical devices, the manufacturer shall submit claims for the ability of manufacturing processes to remove or inactivate transmissible agents, these will be supported by appropriate documentation.
20. To justify the Elimination of factors of the inactivation or, you can use the information from the appropriate scientific literature review and analysis of the literature, this process is comparable to medical device applicable process. In this review and analysis shall also know the electronic check available opinion adopted by the Scientific Committee of the European Union. These findings were used as references, if other findings are inconsistent.
21. If this annex paragraph 20 referred to the literature review could not be found in the grounds of the claim, the manufacturer, subject to the need to carry out a scientific foundation or removal of inactivation, in particular by considering: the specific dangers of 21.1, associated with tissues;
21.2. the description of the relevant model agents;
21.3. the justification for special combinations of model agents the choice;
UR21.4.izv ēlēt the Elimination of transmissible agents or the degree of inactivation;
21.5. the calculation of the reduction factor.
22. The final report describes the manufacturer's parameters and limits that are critical for inactivation or elimination process efficiency.
23. in order to ensure the application of the approved process parameters of daily production, uses detailed documentation of procedures.
2.6. animal tissues or derivatives of the raw material, the quantity required for the production of one medical device manufacturer for 24. assessed supplies tissues or derivatives of animal origin that do not need the one medical device production. If you are involved in the treatment process, the manufacturer shall assess whether it can potentially increase the raw animal tissues or derivatives the existing level of transmissible agents.
2.7. Contact with the patients and users of existing tissues or derivatives of animal origin 25. the manufacturer in relation to the issues considered in this chapter specifically consider: UR25.1.dz īvniek of the tissues or derivatives;
25.2. the face – its area (skin, mucous tissue, brain) and condition (healthy or damaged);
25.3. contact with the patients and users entering the tissues or derivatives;
25.4. the medical device is provided for contact time with the human body (including bioresorption effect);
25.5. the number of medical devices used in a particular procedure.
2.8. Administration 26. take note of the manufacturer in the instructions for use, the label, or other information about the product on the proposed route of administration from the highest to lowest risk.
3. the evaluation report 27. the manufacturer shall establish and maintain a systematic review of the information obtained in the post-production phase of the procedure for medical devices or equivalent devices. The information is evaluated from the potential impact on security aspects, in: 27.1.ir revealed previously unrecognised hazards;
27.2. the risk of danger is no longer permitted;
27.3. the original assessment is otherwise invalidated.
28. If any of the annex referred to in paragraph 27 of the conditions is such as the major, evaluation results returned for inclusion in the risk management process.
29. in the light of this annex, the information referred to in paragraph 27 of the report, the relevant medical devices risk management measures (animal tissues or derivatives selection). If there is a possibility that the risk of residues or its acceptability has changed, re-evaluate and justify the impact on previously implemented risk control measures.
30. This Annex 27, 28 and 29, the results of the evaluation referred to in the document.
4. notified bodies perform a class III medical device evaluation in accordance with the rules of 31 of annex 1 paragraph 27 concerning class III medical devices, the manufacturer shall provide the authority with all information notified to it make the current risk analysis and risk management strategy evaluation. All new information collected by the manufacturer on the TSE risk relating to the medical devices manufactured, it sends a notification to the authority of knowledge.
32. any changes in relation to the determination of origin, collection, processing, inactivation or elimination process and any measure that can convert the manufacturer's risk management documentation, prior to approval the manufacturer shall forward to the notified body an additional approval.
Health Minister g. Smith annex 5 cabinet 2 august 2005 No. 581 of the provisions of the EC declaration of conformity (complete quality assurance system – 93/42-2) (1). the manufacturer, in accordance with paragraph 3 of this annex shall apply to the quality assurance system, which you approved the product development, production and final inspection and covered by this annex, paragraph 3.3 and 4 check referred to in paragraph 5 of this annex and paragraph in the supervision of the European Union.
2. the Declaration of conformity is the procedure whereby the manufacturer who fulfils this add Kuma requirements referred to in paragraph 1, ensures and declares that the products concerned meet the provisions of the laws that apply to them. The manufacturer of the medical device shall be marked with the CE marking and Declaration of conformity statement. This declaration must include a certain number of products manufactured and be kept by the manufacturer.
3. The manufacturer shall submit the application to the Authority reported that in the assessment of his quality system. The application shall include: 3.1. manufacturer's name and address, as well as all additional facilities addresses covered by the quality system;
3.2. all the relevant information about the product or product category covered by the quality system;
3.3. a written declaration that the same application to evaluate product quality system not been lodged with any other eligibility assessed to the authority of other Member States of the European Union;
3.4. quality system documentation;
3.5. the manufacturer's commitment to fulfil the obligations imposed by the approved quality system;
3.6. manufacturer's commitment to maintain the approved quality system adequate and efficacious;
3.7. the commitment of the manufacturer to Institute and keep up to date a systematic procedure to review experience gained after the production of medical devices, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer is to immediately notify the health statistics and medical technologies State Agency for the following incidents: UR3.7.1.par all the parameters or the medical device activities disturbing ating or deterioration, as well as any inadequacy in the instructions for use which might lead to or have led to the death of a patient or user or to a serious deterioration in his State of health;
UR3.7.2.par any technical or medical reason connected with the characteristics or the medical device operation of the same type by the manufacturer to a systematic recall of devices of this Appendix 3.7.1. reasons referred to.

4. application of the quality system shall ensure that at all stages, from design to final inspection products comply with those conditions, the laws which apply to them. All quality system elements, requirements and provisions adopted by the manufacturer must be dokumen dads a systematic and orderly manner in the form of written policies and procedures (quality programmes, quality plans, quality manuals and quality records).
5. Quality System Description: 5.1 the manufacturer's quality objectives;
UR5.2.uz ņēmējdarbīb organization, including: 5.2.1 the organizational structures, the responsibilities of management and organisational powers in respect of product development and quality of production;
5.2.2. the methods of monitoring the efficient operation of the quality system and the ability to achieve the desired production and product quality, including control of products which do not comply;
5.3. product development monitoring and inspection arrangements, providing: 5.3.1. General description of the product, including any variants planned;
5.3.2. a detailed description of the design, indicating the appropriate standards, risk analysis, as well as a description of the solutions adopted to fulfil the essential requirements which apply to them, if the standards have not been applied in full;
5.3.3. the methods used to control and verify the design and processes, as well as regular measures carried out in the course of product development;
5.3.4. If a medical device to make it work per design, are enabled to another medical device or other medical devices, the proof that it complies with the essential requirements, also in connection to another medical device or other medical devices that meet the characteristics specified by the manufacturer;
5.3.5. a statement as to whether the medical device is an integral part of a substance or a human blood derivative, and data on the tests carried out in this respect;
5.3.6. clinical data;
UR5.3.7.eti ķet's sketch and, where appropriate, instructions for use;
5.4. the inspection and quality assurance techniques at the manufacturing stage, including: 5.4.1. processes and procedures which will be used (especially for medical sterilization, purchasing and the relevant documents);
5.4.2. the product identification procedures drawn up and kept up to date at all stages of production, from drawings, specifications or other relevant documents;
5.4.3. the tests and trials which will be carried out before, during and after manufacture, the frequency and the equipment used.
6. the Notified Body shall examine the quality system to determine whether it meets point 5 of this annex to the requirements of, and accepted that a quality system that uses the relevant harmonised standard meets these requirements.
7. Check at least one person with experience in the relevant assessments of technology strategy. The production process of the assessment procedure shall include the manufacturer's, in duly substantiated cases, at the bottom of the manufacturer's suppliers or operators ' premises. The decision shall contain the conclusions of the inspection and a reasoned assessment, and shall notify the manufacturer.
8. The manufacturer shall inform the notified body that has approved the quality times in early stage system of any plan for substantial changes to the quality system or the product-range covered. The notified body shall evaluate the proposed changes and verify whether after these changes the quality system still meets point 5 of this annex to the requirements of, and shall notify its decision to the manufacturer. The decision shall contain the conclusions of the inspection and a reasoned assessment.
9. In addition to obligations which the manufacturer in accordance with this annex 3, 4 and 5, he shall submit the application for the notified body to review the design documentation for those products, which he plans to manufacture and which falls into the annex referred to in paragraph 3 of the category.
10. in paragraph 9 of this annex that describes the product concerned in the application of the design, manufacture and performances of the product, and then add the documents needed to assess whether the product conforms to the requirements of the law.
11. the Notified Body shall examine the application and, if the product meets the Cabinet 2 august 2005 No. 581 of the provisions of the "medical device registration in jas, conformity assessment, distribution, operation and technical procedures in the monitor base" (hereinafter rules) requirements, issue the application with the EC design-examination certificate. The notified body may request further tests or proof to allow assessment of conformity with the requirements of the rules. The certificate shall contain the opinions, validity checks, approved construction of data necessary for the identification and, if necessary, the function of the product description.
12. with regard to medical devices, which are an integral part a substance which, used by itself, can be regarded as medicinal products and interact with people, helping medical device to achieve the desired result, the notified body, in the light of these aspects, before taking a decision, consult the other Member States of the European Union, but the competent authorities for medical devices, which are an integral part of the human blood derivative shall receive the euro pass Medication agency scientific opinion (notified authority may not issue a certificate If you receive an unfavourable opinion of that authority).
13. Each time a change in the approved construction could affect conformity with the essential requirements or the prescribed product functions, its individual approval by the body which issued the EC design-examination certificate. The applicant shall inform the body which issued the EC design-examination certificate of any change which introduced the approved construction. This additional approval shall be drawn up as the EC design-examination certificate.
14. the implementation of the notified body the purpose of surveillance is to ensure that the manufacturer duly fulfils the obligations imposed by the approved quality system to ensure in option 3.
15. The manufacturer shall allow the notified body to carry out all the necessary inspections and shall provide it with all necessary information, including: 15.1. quality system documentation;
15.2. the data stipulated in the part of the quality system relating to design (such as results of analyses, calculation tests);
15.3. the data stipulated in the part of the quality system relating to manufacture of the devices (such as inspection reports and test data, data on catches, kalib the personnel qualification reports).
16. The notified body must periodically carry out appropriate inspections and assessments to make sure that the manufacturer applies the approved quality system and supply the manufacturer with the assessment report.
17. the Notified Body may pay unannounced visits to the manufacturer to verify that the quality system is working properly. during such visits the notified body may, if necessary, carry out or ask for tests. It provide the manufacturer with an inspection report and a report on the trial, if they are carried out.
18. at least five years after the last product has been manufactured, the manufacturer shall keep at the disposal of the national authorities: 18.1. a declaration of conformity;
18.2. to this annex referred to in point 3.4;
18.3. the documentation on this annex referred to in point 8;
18.4. the annex referred to in paragraph 10;
18.5. this annex 6, 11, 13, 16 and 17 of the notified body referred to in decisions and reports.
19.To medical equipment technical documentation, subject to the product's design and verification procedures that the manufacturer or his authorized representative is established in the European Union, keep the person responsible for placing the medical device market in the European Union, or the importer.
20. this annex (except in the 9, 10, 11, 12 and 13) apply to the medical class IIA and IIb devices.
21. upon completion of the harvest of each batch of medical equipment, which is not part of the mam is excluded for a human blood derivative, the manufacturer shall inform the notified body of the release of a batch of medical equipment and supply the appropriate laboratory certificate issued for medical device used in human blood in you the batch release derived.
Health Minister g. Smith annex 6 Cabinet 2 august 2005 Regulations No 581 EC type examination (93/42-3) 1. EC type-examination is the procedure whereby a notified body ascertains and certifies that a representative sample of the production covered in the corresponding Cabinet 2 august 2005 No. 581 of the provisions "of the registration of medical devices, conformity assessment, distribution, ESA pluatācij and technical supervision procedures" (hereinafter referred to as the rules).
2. the application submitted by the manufacturer or its authorised representative, includes: 2.1. manufacturer's name and address, as well as the authorised representative, the name and address of the manufacturer, if the application is lodged by the representative;

2.2. this annex referred to in paragraph 3 of the documentation necessary to evaluate, as representative of the products (hereinafter referred to as the model) meet the requirements of the rules (the applicant shall lodge with the notified body model, and the notified body may, if necessary, request additional samples);
2.3. a written declaration that, in respect of the same model in the application has not been lodged with any other notified body participation in other European Union countries.
3. the documentation submitted by the manufacturer to the notified body, provide a clear picture of the product design, production and operation. The documentation shall contain the following information: 3.1 General description of the model (also all planned variants);
UR3.2.uzb ūv drawings, methods of manufacture envisaged (in particular as regards sterilization), of components, sub-assemblies, circuits and other schemes, as well as the descriptions and explanations necessary to understand the abovementioned drawings, diagrams and the operation of the product;
3.3. full or partial list of the standards applied and a description of the solutions adopted to meet the essential requirements if the standards have not been applied in full;
UR3.4.uzb ūv's calculations, risk analysis, investigations, technical tests, etc.;
3.5. a statement as to whether the medical device is an integral part of any of the substances, used by itself, be regarded as medicinal products and that its effect on people, helps to achieve the desired results, as well as data on tests carried out in this respect;
3.6. a statement as to whether the medical device as an integral part of the composition is incorporated into human blood derivative, and test data.
4. The notified body EC type examination process: 4.1. examine and assess the documentation and verify that the model is manufactured in accordance with that documentation;
UR4.2.re ģistr the individual items, drawn up in accordance with the applicable provisions of the standards, as well as items that are not taken into account in the development of the relevant provisions of those standards;
4.3. carry out or plan for the appropriate inspections and the tests that are not tolerable, to ensure that the solutions adopted by the manufacturer meet the essential requirements if it is not fully applied those standards;
4.4. If a medical device to operate according to its intended purpose, it must switch to another medical device or other devices, obtain the evidence that it complies with the essential requirements, also in connection to another medical device or other devices that have the characteristics specified by the manufacturer;
4.5. perform and plan the appropriate tests and trials which require Shami, to ensure that the standards which the manufacturer intends to apply these have actually been applied;
4.6. agree with the applicant on the place where the necessary inspections and tests.
5. Where the type meets the requirements of the rules, the notified body issues the applicant with an EC type-examination certificate. The certificate shall indicate the name and address of the manufacturer, conclusions of the examination, the conditions of validity of the certificate and the information necessary to identify the approved type. The relevant documentation is added to the certificate, and one of its stores a copy of the notified body.
6. in relation to the medical devices that form an integral part, a substance which is used by itself, be regarded as medicinal products and that its effect on people, helps to achieve the desired result, the notified body shall consult before making a decision with the State Agency of medicines. Notified body accordingly its decision, taking into account the views of the national agency of medicinal products and shall communicate to it their decision.
7. with regard to medical devices which incorporate, as an integral part of the human blood derivative, the scientific opinion of the EMEA. Communication ' authority in making its decision, take into account the opinion of the EMEA, and, on this basis, the certificate may not be issued. In this case, the notified body shall notify its decision to the EMEA.
8. the applicant shall inform the body which issued the EC type-examination certificate of any significant change made to the approved product.
9. If the modifications to the approved design can affect the compliance of the CAI requirements or with the conditions prescribed for use of the product, the changes to the approved product separately approved by the body which issued the EC type-examination certificate. This additional approval is presented as an EC type-examination certificate.
10. other Member States of the European Union notified bodies may obtain EC type-examination certificate, or a copy of the annex. Certificates are available in the annex to the other notified bodies on reasoned application, for it has been informed by the manufacturer.
11. the manufacturer or his authorised representative shall keep copies of EC type-examination certificates and their additions with the technical documentation for at least five years after the last medical device manufacturing.
12. Where neither the manufacturer nor his authorized representative is established in the European Union, technical documentation, the person responsible for placing the apparatus on the circulation in the European Union, or the importer.
Health Minister g. Smith annex 7 Cabinet 2 august 2005 Regulations No 581 EC verification (93/42-4) 1. EC verification is the procedure whereby the manufacturer or his authorised representative established in the European Union, ensures and declares that the products in respect of which made in paragraph 5 of this annex, this procedure complies with the EC type-examination certificate described in the model and the Cabinet 2 august 2005 No. 581 of the provisions of the "medical device registration , conformity assessment, distribution, ESA pluatācij and technical supervision procedures "(hereinafter referred to as the rules).
2. The manufacturer shall take all measures necessary to ensure that the manufacturing process produces products which conform to the type described in the EC type-examination certificate and the appropriate requirements of the rules. Before you begin production the manufacturer shall prepare a document describing the production process (in particular as regards sterilization, if it is needed, as well as the progress of work, previously developed conditions that must be met to ensure the homogeneity of production and, where appropriate, the conformity of the products with the EC type described in the certificate of pleasure over the model and the requirements of the rules).
3. the manufacturer shall affix to the product with the CE marking and draws up the compliance de do. In the case of products placed in circulation a sterile form, and only for those aspects of the manufacturing process designed to secure sterility and conservation of šināšan, the manufacturer applies the rules referred to in annex 8 of the relevant conditions.
4. The manufacturer shall undertake to Institute and keep up to date a systematic procedure to review by medical equipment manufacturing experience and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer is to immediately notify the health statistics and medical technologies State Agency for the following incidents: UR4.1.par all parameters of the medical device or malfunction or deterioration, as well as any inadequacy in the labelling or the instructions for use which might lead to or have led to the death of a patient or user or to a serious deterioration in his State of health;
UR4.2.par any technical or medical reason connected with the characteristics or the medical device activities where devices of the same type by the manufacturer regularly removed from circulation due to this annex referred to in point 4.1 below.
5. in order to verify conformity with the requirements of the rules, the notified body according to the manufacturer's decision to carry out appropriate inspections and test you, either in the examination and testing of every product in accordance with paragraph 6 of this annex, or by examination and testing of products in accordance with this statistical annex 7. These checks shall not apply to aspects of the production process, designed to ensure sterility.
6. Verification by examination and testing of every product, means that: 6.1. every product is examined individually and in order to verify responses of this type-examination certificate as described in the EC model and the requirements of the rules concerned, perform appropriate tests according to relevant standard or equivalent test;
6.2. the notified body shall each approved product marked with the identification number or, if the product is already affixed, draws up a written certificate of conformity relating to the tests carried out.
7. statistical verification means that: 7.1 the manufacturer presented products produced form of homogeneous lots;
7.2.no each party having a random sample. Sample product tested individually and the appropriate tests, as specified in the relevant standards or, if necessary, equivalent tests, to check the conformity of the type-examination certificate as described in the EC model and the requirements of the rules concerned and determine whether the party can approve or reject;

6.3. statistical control of products will be based on attributes, entailing a sampling system ensuring a limit quality corresponding to a probability of acceptance of 5%, with a 3-7%. The introduction of sampling method according to harmonised standards, taking into account the special nature of the product categories;
7.4. If the batch is accepted, the notified body shall be marked with the product identification number information and draws up a written certificate of conformity relating to the izmēģ in the early stage. All the party products (except the corresponding samples) may be put into circulation;
7.5. If a lot is rejected, the notified body shall take appropriate measures to prevent the batch from being placed on the circulation. If the lots are often rejected, the notified body may suspend the statistical verification.
7.6. the production process of the medical device manufacturer can be marked with the identification number of the notified body, if it is authorized by the appropriate authority.
8. at least five years after the last product has been manufactured, the manufacturer or his authorised representative shall keep at the disposal of the national authorities: 8.1. certificate of conformity;
8.2. this annex, point 2 and 3 of the said dossier;
8.3. this annex 6.2. and 7.4. certificates referred to;
8.4. If necessary, the rules referred to in annex 6 of the type-examination certificate.
9. this annex applies to class II medical devices that are subject to the following exceptions: UR9.1.atk āpjot of this annex 1, 2 and 3 referred to in paragraph nosacīj of the rules and on the basis of the Declaration of conformity the manufacturer ensures and declares that the class II medical devices are manufactured in accordance with the rules referred to in annex 9 of the technical documentation and satisfy the relevant requirements of the rules;
UR9.2.atk āpjot of this annex 1, 2, 3, 6, and 7 the conditions referred to in paragraph, the notified body shall confirm the verification of class II products comply with rule 9. technical documentation referred to in the annex.
10. with regard to paragraph 6 of this annex, complete producing each batch of medical equipment that is an integral part, a human blood derivative, and verification in accordance with point 7 of this annex, the manufacturer shall inform the notified body of the release of a batch of medical equipment and supply the appropriate laboratory official issued an opinion on the medical device in human blood derivative used in the batch release.
Health Minister g. Smith Annex 8 Cabinet 2 august 2005 No. 581 of the provisions of the EC declaration of conformity (production quality assurance – 93/42-5), 1. the manufacturer shall apply the quality system approved for the manufacture of the products concerned and subject to this annex referred to in paragraph 4 of the European Union monitoring, and make a final inspection in accordance with paragraph 3 of this annex.
2. the Declaration of conformity is the part of the procedure whereby a manufacturer who fulfils this referred to in paragraph 1 of the annex, ensures and declares that the products concerned conform to the EC type-examination certificate and to the type described in those conditions, the laws which apply to them.
3. the manufacturer of the medical device shall be marked with the CE marking and Declaration of conformity statement. Declaration of conformity covers a certain number of identified products look and keep Guus manufacturer.
4. the manufacturer shall provide the notified body application request an assessment of his quality system. The application shall include: 4.1 the name and address of the manufacturer;
4.2. all relevant information relating to a product or product category covered by the procedure;
4.3. a written declaration that the application provides the quality evaluation system of šinājum not been lodged with any other notified body in other Member States of the European Union;
4.4. quality system documentation;
4.5. the manufacturer's commitment to fulfil the obligations imposed by the approved quality system;
4.6. the manufacturer's commitment to maintain the approved quality system usability and effectiveness;
4.7. If necessary, the technical documentation relating to the approved models, and selected in the copy of the EC type-examination certificate;
4.8. the commitment of the manufacturer to Institute and keep up to date a systematic procedure to review experience gained after the production of medical devices, and to implement appropriate means to apply any necessary corrective action.
5. This annex 4.8 commitment referred to provides that it is the responsibility of the manufacturer to immediately notify the health statistics and medical technologies State Agency for the following incidents: UR5.1.par all parameters of the medical device or malfunction or deterioration, as well as any inadequacy in the labelling or the instructions for use which might lead to or have led to the death of a patient or user or to a serious deterioration in his State of health;
UR5.2.par any technical or medical reason connected with the characteristics or the medical device activities where devices of the same type by the manufacturer regularly removed from circulation due to this annex referred to in 5.1.
6. application of the quality system shall ensure that the products conform to the EC type-examination certificate described in the model. All quality system elements, requirements and provisions adopted by the produce saver, documented in a systematic and orderly manner in the form of written policies and procedures. This quality system documentation shall permit uniform interpretation of the quality policies and procedures (such as quality programmes, plans, manuals and quality records).
7. Quality System Description: 7.1 the manufacturer's quality objectives;
UR7.2.uz ņēmējdarbīb structure, in particular: 7.2.1. organisational structures, the responsibilities of the Organizer, the hook and the authority where manufacture of the products;
7.2.2. the methods of monitoring the efficient operation of the quality system and the ability to achieve the desired quality of product, including control of products which do not comply;
7.3. the inspection and quality assurance techniques at the manufacturing stage, in particular: 7.3.1. processes and procedures which will be used (in particular as regards sterilization, purchasing and the relevant documents);
7.3.2. the product identification procedures drawn up and kept up to date in all stages of production, from drawings, specifications or other relevant documents;
7.3.3. the tests and trials carried out before, during and after manufacture, and the frequency of use of the equipment.
8. The notified body shall check that the quality system to determine whether they comply with this annex in paragraphs 6 and 7 of these requirements, and shall adopt, in respect of quality systems that implement the harmonized standards that meet these requirements. The test will involve at least one person with experience of assessments of the technology concerned. Production process the assessment process provides the manufacturer's, in duly justified cases, the manufacturer's piegādātājfirm space. The decision shall contain the conclusions of the inspection and a reasoned assessment, and decision is notified to the manufacturer after the final inspection.
9. The manufacturer shall inform the body which approved the quality system of any plan for substantial changes to the system. The said authority shall evaluate the changes proposed and verify whether after these changes the quality system still meets the 6 and 7 of this annex to the requirements of paragraph, and shall notify its decision to the manufacturer. The decision shall contain the conclusions of the inspection and a reasoned assessment.
10. the manufacturer shall authorize the notified body to carry out all the necessary inspections and shall provide it with all necessary information, including: 10.1. quality system documentation;
10.2. the data stipulated in the part of the quality system relating to production (such as inspection reports and test data, calibration data, qualification reports of the personnel concerned).
11. The notified body must periodically carry out appropriate inspections and assessments to make sure that the manufacturer applies the approved quality system and supply the manufacturer with an assessment report.
12. the Notified Body may pay unannounced visits to the manufacturer to verify that the quality system is working properly. During such visits the notified body may, if necessary, carry out or ask for tests. It provide the manufacturer with an inspection report and test report, if the trial is conducted.
13. at least five years after the last product has been manufactured, the manufacturer shall keep at the disposal of the national authorities the following documents: 13.1. a declaration of conformity;
13.2. the quality system documentation;
13.3. documentation on this in paragraph 9 of the annex to these changes;
13.4. this annex 4.7. documentation referred to;
13.5. this annex 9 and paragraph 11 the notified body referred to in decisions and reports;

13.6. where applicable, the Cabinet 2 august 2005 No. 581 of the provisions "of the registration of medical devices, conformity assessment, distribution, operation and technical monitoring procedures" (hereinafter rules) 6. referred to in the annex to the type-examination certificate.
14. this annex applies to class II products covered by the following exception-by way of derogation from point 2, 4, 5 and 6 of these requirements and on the basis of the Declaration of conformity the manufacturer ensures and declares that the products in class IIA are manufactured in conformity with the rules referred to in annex 9 of the technical documentation and meeting the requirements of this regulation.
15. When finished to produce each batch of medical equipment that is an integral part of the human blood derivative, the manufacturer shall inform the notified body of the following medical device batch release and shall forward to it a certificate issued by the appropriate laboratory of the medical device in human blood derivative used in the batch release.
Health Minister g. Smith 9. Cabinet of Ministers of 2 august 2005 No. 581 of the provisions of the EC declaration of conformity (93/42-7) (1). The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative, the company running this annex referred to in paragraph 2, but in the case of products (medical devices, components and spare parts), which is marketed in a sterile State and devices with a measuring function, in paragraph 5 of this annex, these obligations and ensures and declares that the products concerned satisfy the requirements of this regulation.
2. the manufacturer shall prepare this annex referred to in paragraph 3 of the technical document. The manufacturer or his authorized representative shall ensure that the information in that document (including the Declaration of conformity) the national authorities for inspection purposes be available for at least five years after the last product has been manufactured. If the European Union is not registered in neither the manufacturer nor his authorised representative, the obligation to keep the technical documentation available shall be the person or persons that the product marketed in the European Union.
3. The technical documentation must be such as to enable the conformity of the Cabinet of Ministers of 2 august 2005 No. 581 of the provisions of the "electronic check at registration the Medic, conformity assessment, distribution, operation and technical supervision procedures" (hereinafter referred to as the rules). The technical documentation shall include: 3.1 General description of the product, including any variants planned product;
UR3.2.uzb ūv drawings, methods of manufacture envisaged, as well as of components, sub-assemblies, circuits and other schemes;
3.3. the descriptions and explanations necessary for the understanding of this put ma 3.2 drawings, referred to schemes and medical device;
3.4. results of risk analysis and the application of all or part of the list of standards, as well as a description of the solutions adopted to meet the essential requirements if the standards have not been applied in full;
3.5. in relation to products put into circulation in sterile condition, description of the methods of sterilization used;
3.6. the design calculations and of the inspections carried out and other results;
3.7. If the medical device is to act according to its intended purpose, it must be connected to other medical devices or other devices, the proof that it complies with the essential requirements, also in connection to another medical device or other devices that have characteristics specified by the manufacturer;
UR3.8.izm ēģinājum and, if necessary, clinical data;
UR3.9.eti ķet and instructions for use.
4. The manufacturer shall Institute and keep up to date a systematic procedure to review experience gained after the production of medical devices, and to implement appropriate means to apply any necessary corrective actions, taking account of the nature and risks in relation to the product. It is the responsibility of the manufacturer to immediately notify the health statistics and medical technologies State Agency for the following incidents: UR4.1.par all parameters of the medical device or malfunction or deterioration, as well as any inadequacy in the labelling or the instructions for use which might lead to or have led to the death of a patient or user or to a serious deterioration in his State of health;
UR4.2.par any technical or medical reason connected with the characteristics or the medical device activities where devices of the same type by the manufacturer systematically removed from circulation due to this annex referred to in point 4.1 of the reasons.
5. in relation to products put into circulation in sterile condition and class I devices with a measuring function, the manufacturer followed not only the conditions referred to in this annex but also one of rules 7, 8, or 10. the procedures referred to in the annex. The application of the abovementioned annexes and the health statistics and medical technologies State Agency intervention limit: 5.1 in respect of products placed in circulation a sterile way – with those aspects of the manufacturing process for sterile conditions and maintenance;
5.2. for measuring only the aspects of manufacture concerned with the conformity of the products with the metrological requirements.
6. this annex applies to class II products subject to the following exception: If this annex is applied in conjunction with the procedure referred to in rules 7, 8, or 10. the said annexes annex, specified in the Declaration of conformity is the Joint Declaration. With regard to the Declaration contained in the annex to this manufacturer ensures and declares that the product development meet the requirements of the rules.
Health Minister g. Smith 10. attachment Cabinet 2 august 2005 No. 581 of the provisions of the EC declaration of conformity (product quality approval-93/42-6) (1). the manufacturer shall apply the quality system approved for the final product, attractive stand for inspection and testing. In the case of products placed in circulation a sterile way, and with respect to aspects of the manufacturing process designed to secure sterility and retention, the manufacturer applies the Cabinet 2 august 2005 No. 581 of the provisions "of the registration of medical devices, conformity assessment, distribution, operation and technical monitoring procedures" (hereinafter rules) referred to in annex 8.
2. the Declaration of conformity is the part of the order in which the manufacturer fulfils this referred to in paragraph 1 of the annex, ensures and declares that the products concerned conform to the EC type-examination certificate described in the model and the requirements of the rules.
3. the manufacturer shall affix to the product with the CE marking and Declaration of conformity statement. Declaration of conformity covers a certain number of identified specimens of the products, and it stores the manufacturer. Located next to the CE notified body identification number.
4. the manufacturer shall provide the notified body application request an assessment of his quality system. The application shall include: 4.1 the name and address of the manufacturer;
4.2. all the relevant information about the product or product category covered by the procedure;
4.3. a written declaration that the application with respect to this product not been lodged with any other notified body in the Member States of the European Union;
4.4. quality system documentation;
4.5. the manufacturer's commitment to fulfil the obligations imposed by the approved quality system;
4.6. the manufacturer's commitment to maintain the approved quality system effective;
4.7. If necessary, the technical documentation on the types approved and the EC type-examination certificate;
4.8. the commitment by the manufacturer to Institute and keep up to date a systematic procedure to review experience gained after the production of medical devices, and to implement appropriate means to apply any necessary corrective action.
5. This annex 4.8 commitment referred to provides that it is the responsibility of the manufacturer to immediately notify the health statistics and medical technologies State Agency for the following incidents: UR5.1.par all parameters of the medical device or malfunction or deterioration, as well as any inadequacy in the labelling or the instructions for use which might lead to or have led to the death of a patient or user or to a serious deterioration in his State of health;
UR5.2.par any technical or medical reason connected with the characteristics or the medical device operation of the same type by the manufacturer of the medical device will be systematically removed from circulation due to this annex referred to in point 5.1. bottom.

6. Each batch each product or sample of the product in accordance with the quality system examination and appropriate tests, as specified in the relevant standards, or equivalent tests, to test the product is in conformity with the scope described in the EC type-examination certificate and the model and rules. All elements of the quality system, requirements and conditions which comply with the manufacturer shall be documented in a systematic and orderly manner in the form of written measures, procedures and instructions. This quality system documentation shall always permit uniform interpretation of the quality provide you the programmes, quality plans, quality manuals and quality records.
7. Quality System Description: 7.1 the quality objectives, the organizational structure, management must arrive and powers with regard to product quality;
7.2. the examinations and tests that will be carried out after manufacture;
7.3. the methods of monitoring the efficient operation of the quality system;
7.4. quality records.
8. paragraph 6 of this annex, the checks referred to does not apply to those aspects of the manufacturing process designed to ensure sterility.
9. the Notified Body shall examine the quality system to determine whether it corresponds to this annex in paragraphs 7 and 8 of the said requirements, and shall adopt, in respect of quality systems that use the relevant harmonised standard meets these requirements. The test will involve at least one person with the vision of assessments of the technology concerned. Production process the assessment process provides the manufacturer's, in duly justified cases, the manufacturer's piegādātājfirm space. The decision shall contain the conclusions of the inspection and a reasoned assessment, and decision is notified to the manufacturer.
10. The manufacturer shall inform the body which approved the quality system of any plan for substantial changes to the system. The said authority shall evaluate the changes proposed and verify whether after these changes the quality system still meets the present annex, paragraph 7 and 8 of the said requirements, and shall notify its decision to the manufacturer. The decision shall contain the conclusions of the inspection and a reasoned assessment.
11. The manufacturer shall allow the notified body to carry out all the necessary inspections (including laboratory and warehouse inspection), and shall provide it with all necessary information, including: 11.1. quality system documentation;
11.2. technical documentation;
11.3. quality records (such as inspection reports, test data, calibration data, qualification reports of the personnel concerned).
12. The notified body must periodically carry out appropriate inspections and assessments to make sure that the manufacturer applies the quality system and provide the manufacturer with an assessment report.
13. the Notified Body may pay unannounced visits to the manufacturer. During such visits the notified body may, if necessary, carry out or ask for tests in order to check that the quality system is working properly and that the production conforms to the requirements of the law. For this purpose, check the appropriate proportion of the samples on the spot chosen by the notified body, as well as the pilot for the respective stan darto, or other equivalent tests. If one or more of the samples do not meet the eligibility requirements, the notified body shall take the necessary measures to prevent such medical devices in circulation, as well as provide the manufacturer with an inspection report and test report, if the trial is conducted.
14. at least five years after the last product has been manufactured, the manufacturer shall keep at the disposal of the national authorities the following documents: 14.1. a declaration of conformity;
14.2. this annex 4.7. documentation referred to;
14.3. the documentation on this in paragraph 10 of the annex to these changes;
14.4. this annex 10, paragraphs 12 and 13 of the notified body referred to in decisions and reports;
14. where applicable, the rules referred to in annex 6 of the certificate of conformity.
15. this annex applies to class II products covered by the following exception-by way of derogation from point 2, 4, 5 and 6 of these requirements and on the basis of the Declaration of conformity the manufacturer ensures and declares that the products in class IIA are manufactured in conformity with the rules referred to in annex 9 of the technical documentation and meet the requirements of the rules.
Health Minister g. Smith 11. Annex Cabinet 2 august 2005 Regulations No 581 notice of devices intended for special purposes (93/42-8) 1. In regard to the medical mind, ie custom-made or intended for clinical investigations, the manufacturer or his authorised representative shall draw up the statement containing the annex referred to in paragraph 2.
2. The notification shall contain: 2.1. with regard to medical devices made to order: 2.1.1. data identifying the specific medical device;
2.1.2. a notice stating that the medical device is intended only for a specific patient (the patient's first and last names);
2.1.3. the medical practitioner or other authorized person's name and last name that made statements and, if necessary, the hospital's name;
2.1.4. the medical device specific features according to the medical statement;
2.1.5. a statement indicating that a particular medical device complies with the essential requirements and, where appropriate, an indication that the essential requirements of the medical device is only partially, as well as such derogations;
2.2. with respect to clinical trials for medical devices: 2.2.1. data identifying the specific medical device;
2.2.2. study plan, in particular the objective of medical equipment, scientific, technical or medical grounds, scope and number of devices at schools, medic;
2.2.3. the opinion of the Ethics Committee and its detailed description of the covered aspects;
UR2.2.4.par research in charge of the medical practitioner or other authorized person's name and of the institution responsible for the investigations;
2.2.5. the study location, start date and scheduled duration;
2.2.6. a statement indicating that a particular medical device complies with the essential requirements, except for the aspects of the study object, and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.
3. with regard to medical devices made to order, the manufacturer shall keep the health statistics and medical technologies State agency needs documentation allowing an understanding of the structure, medical equipment production and action (action for the well), so as to allow assessment of conformity with the Cabinet 2 august 2005 No. 581 of the provisions "of the registration of medical devices, conformity assessment, distribution, operation and technical base in order monitor".
4. Clinical investigations of medical devices intended for documentation that is stored in the health statistics and medical technologies State agency needs, include: 4.1 General description of the product;
UR4.2.uzb ūv drawings, methods of manufacture envisaged (in particular as regards sterilization), as well as of components, sub-assemblies, circuits and other schemes;
4.3. the descriptions and explanations necessary to understand the abovementioned drawings, diagrams and the operation of the product;
4.4. results of risk analysis and the application of all or part of the list of standards, as well as a description of the solutions were applied in order to comply with the essential requirements, if not fully applied those standards;
4.5. the design calculations, checks and technical tests results.
5. the manufacturer shall take all measures necessary to ensure that the manufacturing process produces products which are manufactured in accordance with this annex, paragraph 3 of the documentation. The manufacturer allows the evaluation of the effectiveness of these measures or, if necessary, audits.
6. the notices referred to in this annex, the information contained in the manufacturer kept for at least five years.
Health Minister g. Smith 12. attachment Cabinet 2 august 2005 No. 581 of the provisions of the EC declaration of conformity (full quality assurance system-90/385-2) (1). the manufacturer, in accordance with this annex 6, 9, 10, 11 and 12 shall apply the quality system approved for the development of the product concerned, the production and inspection, and fully covered by this annex, 13, 14 and 15 above, the European Union's monitoring.

2. the Declaration of conformity is the procedure whereby a manufacturer who fulfils this annex referred to in paragraph 1, guarantees and officially declare that the products concerned conform to the Cabinet of Ministers of 2 august 2005 No. 581 of the provisions "of the registration of medical devices, conformity assessment, distribution, ESA pluatācij and technical monitoring procedures" (hereinafter rules) requirements that apply to them. Manufacturers or their authorised representatives medical devices marked with the CE marking and draw up a written declaration of conformity. Declaration of conformity applies to one or more identifiable maritime industries and services, and the look of the product shall be kept by the manufacturer or his authorized representative. The CE marking shall be accompanied by the identification number of the notified body.
3. the manufacturer shall provide the notified body application request an assessment of his quality system. The application shall include: 3.1 for all relevant information for the product category that provides for the making;
3.2. the quality system documentation;
3.3. the manufacturer's commitment to fulfil the obligations imposed by the approved quality system;
3.4. the manufacturer's commitment to maintain the approved quality system adequate and efficacious;
3.5. the manufacturer's commitment to Institute and keep up to date on the electronic check sales medic device monitoring system.
4. the quality system shall be an obligation for the manufacturer to prevent drawing to inform the health statistics and medical technologies State Agency for the following incidents: UR4.1.par all parameters of the medical device or malfunction or deterioration, as well as any inadequacy in the instructions for use which might lead to or have led to the death of a patient or to a serious deterioration in his State of health;
UR4.2.par any technical or medical reason resulting manufacturer medical device removed from circulation.
5. The quality system must ensure that at all stages, from design to final inspection of those products comply with the requirements of the rules that apply to them. All the quality of the elements, requirements and provisions manufacturers are documented in a systematic and orderly manner in the form of written des inspections and procedures. This quality system documentation shall always allows a uniform interpretation of the quality policies and procedures (for example, quality Pro gramm, quality plans, quality manuals and quality records).
6. Quality system description in detail: 6.1 the manufacturer's quality objectives;
UR6.2.uz hospitality structures structure, in particular: 6.2.1 organizational structures, the responsibilities of the joint powers and managerial issues related to design and product quality;
6.2.2. the methods of monitoring the effective operation of the quality assurance system and the ability to achieve the desired development and product quality, as well as control which products fail to conform;
6.3. test procedures for product development for monitoring and verifying in particular: 6.3.1. project (also at the applicable standards), as well as a description of the solutions, which are used to make the product comply with the essential requirements if the standards applied only in part;
6.3.2. the design, process and systematic action for the control and verification techniques to be used for product development;
6.4. control and quality assurance techniques at the manufacturing stage, in particular: 6.4.1. processes and procedures which will be used (in particular as regards sterilization, medical equipment sales and relevant documentation);
6.4.2. the product identification procedures drawn up and kept up to date, at all stages of manufacture using drawings, detailed technical descriptions or other relevant documentation;
6.5. before, during and after the tests and trials to be carried out, their frequency, and the test equipment used.
7. The notified body shall check that the quality system to determine whether they comply with paragraph 6 of this annex to the requirements of, and believes that the quality assurance system, which uses the relevant harmonised standard meets these requirements. The test will involve at least one person with experience of assessments of the technology concerned. The test will also include the manufacturer's. The decision shall contain the conclusions of the inspection and a reasoned assessment, and decision is notified to the manufacturer after the last inspections.
8. the authority which has approved the quality system, the manufacturer is informed of any plan for substantial changes to the system. The said authority shall evaluate the changes proposed and verify whether after these changes the quality system still meets the point 6 of this annex to the requirements of, and communicate its decision to the manufacturer. The decision includes inspections and by conclusion must pale.
9. In addition to obligations which the manufacturer in accordance with paragraph 6 of this annex, the manufacturer shall submit the application, which asks to examine the product documentation, which he plans to make.
10. in paragraph 9 of this annex that describes the product concerned in the application project, the manufacturing process and functions provide the necessary data to allow an assessment to be made of the conformity of production requirements. The application includes: 10.1. project detailed description (including appropriate standards);
10.2. the application of appropriate standards of evidence (especially if the standards have been applied only in part). In these evidence include the results of the examinations carried out by the manufacturer or on his behalf;
10.3. the Act on it, or part of the medical device is or is not one of the substances, which together with the medical device can be used in biological as well as data on the relevant trials;
10.4. clinical data;
10.5. the instructions for use.
11. The notified body shall examine the application and, if the product meets the requirements of the rules, issue an EC design examination certificate. The notified body may require the application to add the data about other checks or additional proof to allow assessment of conformity with the requirements of the rules. The said certificate is the conclusions of the examination, conditions for its validity, the necessary data for identification of the approved projects, and, if necessary, the intended function of the product description.
12. the body which issued the EC design examination certificate informed of all modifications to the approved applicant project modifications. If modifications to the approved design may affect conformity with the essential requirements or the intended functions of the product, its separately approved by the body that issued the EC design-examination certificate. This additional permit is issued as a supplement to the EC design-examination certificate.
13. The manufacturer shall allow the notified body to carry out all the necessary inspections and shall provide it with all necessary information, including: 13.1. the quality assurance system documentation;
13.2. data provided for part of the quality system relating to design;
13.3. the data stipulated in the part of the quality system relating to manufacture of the devices.
14. The notified body must periodically carry out appropriate inspections and assessments to make sure that the manufacturer applies the approved quality system and supply the manufacturer with an assessment report.
15. the Notified Body may arrive without warning to producers and sent them reports on inspections.
16. at least five years after the last product has been manufactured, the manufacturer shall keep at the disposal of the national authorities: 16.1. a declaration of conformity;
16.2. the quality assurance system documentation;
16.3. to this annex referred to in point 8 amendment;
16.4. this paragraph 10 of the annex to the said dossier;
16.5. this annex 8, 11, 14 and 15 of the notified body referred to in decisions and reports.
17. Upon receipt of the health statistics and honey fight technology government agency provides other European Union Member States competent authorities with all the information you need about quality system approvals it refused or withdrawn.
18. Where neither the manufacturer nor his authorized representative is established in the European Union, technical documentation available for the health statistics and medical technologies State Agency to ensure the person responsible for the distribution of medical devices.
Health Minister g. Smith 13. attachment Cabinet 2 august 2005 Regulations No 581 EC type examination (90/385-3) 1. EC type-examination is the procedure whereby a notified body certifies that the intended representative samples of the product complies with the relevant cabinet 2 august 2005 No. 581 of the provisions "of the registration of medical devices, conformity assessment, distribution, ESA pluatācij and technical supervision procedures" (hereinafter referred to as the rules).
2. the manufacturer or his authorized representative shall submit the notified body an application which requested the EC type-examination. The application shall contain: 2.1. manufacturer's name and address, as well as the authorized representative's name and address if the request is lodged by the authorized representative;

2.2. written declaration that the application has not been lodged with any other notified body in other Member States of the European Union;
2.3. the annex referred to in paragraph 4 of the documentation necessary to assess how representative the product concerned (hereinafter type) meet the requirements of the rules.
3. The applicant shall be referred to the notified body type. If necessary, the notified body may ask you to submit additional types.
4. EC type-examination documentation provides a clear picture of the design, manufacture and operation of the product. The documentation shall contain the following information: 4.1 General description of the type;
4.2. design drawings, methods of manufacture envisaged (in particular as regards sterilization), as well as of components, sub-assemblies, circuits, etc. of the chains of charts;
4.3. the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product;
4.4. full or partial list of the standards applied and a description of the solutions selected to design the meet the essential requirements if the standards have not been applied in full;
4.5. the calculation of the project, research, technical inspection, etc. required test results;
4.6. provisions concerning that part of the medical device is one of the substances, which together with the medical device can be used in biological as well as data on tests carried out accordingly;
4.7. clinical data;
4.8. the instructions for use.
5. The notified body EC type examination process: 5.1. examine and assess the documentation and verify that the type produced in accordance with that documentation;
UR5.2.re ģistr elements, drawn up in accordance with the applicable standards, as well as elements that projects do not take into account the relevant standards;
5.3. carry out the appropriate inspections and the tests necessary to transfer the cināto that the solutions adopted by the manufacturer meet the essential requirements if it is not fully applied the standards referred to above;
5.4. carry out appropriate inspections and examinations necessary to make sure that it is actually applied the standards expected by the manufacturer;
3.4. agree with the applicant that the necessary inspections and tests.
6. Where the type meets the requirements of these provisions, the notified body shall issue the applicant with an EC type-examination certificate. The certificate shall indicate the name and address of the manufacturer, conclusions of the examination, the conditions of validity of the certificate and shall keep the information necessary to enable them to the approved type. The most important document of attestation, added tation! and the notified body shall keep one copy.
7. the body which issued the EC type-examination certificate, the applicant is informed of all modifications to the approved product. If the manufacture of the approved ma modifications may affect conformity with the essential requirements or the prescribed conditions for use of the product, modifications to the approved product receives its authority, which issued the EC type-examination certificate. This new permit is issued as the first of the EC type-examination certificate.
8. upon request, the notified body must give the other European Union Member States and the notified bodies all relevant information on EC type-examination certificates and addenda issued, refused or withdrawn.
9. The other notified bodies may obtain EC type-examination certificate, or a copy of the annex. The annexes to the certificates other notified bodies on reasoned request, receive and the manufacturer's information.
10. the manufacturer or his authorised representative in the EC type-examination certificates and their annexes shall keep with the technical documentation a copy of at least five years after the last medical device manufacturing.
11. Where neither the manufacturer nor his authorized representative is established in the European Union, for storing technical documentation is the responsibility of the person who is answering the seed medical devices into circulation within the European Union.
Health Minister g. Smith annex 14. Cabinet 2 august 2005 Regulations No 581 EC verification (90/385-4) 1. EC verification is the procedure whereby the manufacturer or his authorised representative established in the European Union, ensures and declares that the products covered by this annex for the conditions referred to in paragraph 3, comply with the type as described in the EC type-examination certificate and apply to them the Cabinet 2 august 2005 No. 581 of the provisions of the "medical device registration , conformity assessment, distribution, ESA pluatācij and technical supervision procedures "(hereinafter referred to as the rules).
2. the manufacturer or his authorised representative established in the European cou childhood, shall take all the measures necessary in order that the manufacturing process ensures conformity of the products with the type as described in the EC type-examination certificate and with the provisions which apply to them. The manufacturer or his authorized representative established in the European Union, each product is marked with CE marking and draw up a written declaration of conformity.
3. before the start of manufacture the manufacturer shall prepare the documents defining the manufacturing processes (specifically processes related to sterilization), and also includes all the usual conditions that must be met in order to ensure uniformity of production and the conformity of the products with the type as described in the EC type-examination certificate and with the requirements of the rules.
4. the manufacturer shall undertake to create and constantly update the post-market surveillance system. This obligation includes the obligation for the manufacturer to immediately notify the health statistics and medical technologies State Agency for the following incidents: UR4.1.par any changes to medical device characteristics or performances and any inaccuracies in medical devices, the instructions for use which might lead to or have led to the death of a patient or to a serious deterioration in his State of health;
UR4.2.par any technical or medical reason resulting manufacturer medical device removed from circulation.
5. the Notified Body shall carry out the appropriate tests to determine product compliance with the requirements of the rules, based on a statistical examination of the product in accordance with paragraph 6 of this annex. The manufacturer authorizes the notified body, if necessary, take the test, evaluate, in accordance with paragraph 3 of this annex, the effectiveness of the measures taken.
6. statistical verification means that: 6.1. manufacturers shall present the products manufactured in the form of uniform batches and shall take all the necessary šamo measures in order that the manufacturing process ensures the uniformity of each batch;
6.2. the notified body a random sample shall be taken from each batch. Within each sample product tested separately in accordance with the appropriate standards or making them equivalent to testing to verify the conformity of the products with the type as described in the EC type-examination certificate and determine if the lot must be accepted or rejected;
6.3. statistical control of products will be based on the following criteria, including random system characteristics: 6.3.1.95% quality according to a probability of acceptance of 0.29-1% with compliance;
6.3.2. a limit quality corresponding to a probability of acceptance of 5%, with a 3-7%.
7. If the batch is accepted, the notified body shall affix the identification number or affixed to each product and controls made accordingly draw up a written declaration of conformity. All serial or batch of products (except for products in the sample which were found not to be adequate) may be put into circulation. If a lot is rejected, the notified body shall take appropriate measures to prevent this series or the placing on the market of the party. In the event of frequent rejection of lots the notified body may suspend the statistical verification. The manufacturer may affix the identification number of the manufacturing process only with the permission of the notified body.
8. the manufacturer or his authorized representative is ready to produce, on request, or present certificates of conformity.
Health Minister g. Smith annex 15. Cabinet 2 august 2005 Regulations No 581 EC declaration of conformity to type (production-quality assurance-90/385-5) 1. the manufacturer shall apply the quality system approved for the manufacture of the product, and do a final check of the product concerned in accordance with this annex 4, 5, 6, 7, 8 and 9, and to the producers of annex 10, 11 and 12 of the monitoring referred to in paragraph 1.
2. the Declaration of conformity shall belong to the procedure whereby a manufacturer who fulfils this referred to in paragraph 1 of the annex, ensures and declares that the products concerned conform to the EC type-examination certificate and to the type as described in the Cabinet-2 august 2005 No. 581 of the provisions "of the registration of medical devices, conformity assessment, distribution, operation and technical supervision procedures" (hereinafter referred to as the rules).
3. The manufacturer, or his authorised representative established in the medical devices marked with the CE marking and draw up a written declaration of conformity. This declaration shall cover one or more of the labelled specimens of the product and shall be kept by the manufacturer. The CE marking shall be accompanied by the identification number of the notified body.

4. the manufacturer shall provide the notified body application request an assessment of his quality system. The application shall include: 4.1. production of medical devices;
4.2. the quality system documentation;
4.3. the commitment to fulfil the obligations imposed by the approved quality system;
4.4. the commitment to maintain the approved quality system adequate and efficacious;
4.5. If necessary, the technical documentation relating to the approved type and a copy of the EC type-examination certificate;
4.6. the manufacturer's commitment to implement and regularly update drafting sold you the maintenance system.
5. the producer is obliged to immediately notify the health statistics and medical technologies State Agency for the following incidents: UR5.1.par every medical device deterioration in the characteristics or performances and any inaccuracies in the instructions for use which might lead to or have led to the death of a patient or to a serious deterioration in his State of health;
UR5.2.par any technical or medical reason resulting manufacturer medical device removed from circulation.
6. All the elements, requirements and rules which follow the Kuma manufacturer shall be documented in a systematic and orderly manner in the form of written policies and procedures. This quality system documentation shall always allows a uniform interpretation of the quality policies and procedures (such as quality programmes, quality plans, quality manuals and quality records).
7. Quality system description in detail: 7.1 the manufacturer's quality objectives;
UR7.2.uz hospitality structures structure, in particular: 7.2.1. organisational structures, the responsibilities of the Organizer, the hook and the authority where manufacture of the products;
7.2.2. the methods of monitoring the efficient operation of the quality system and the ability to achieve the desired development and product quality, as well as control which products fail to conform;
7.3. control and quality assurance techniques at the manufacturing stage, in particular: 7.3.1. processes and procedures which will be used (especially for medical sterilization and disposal);
7.3.2. the product identification procedures drawn up and kept up to date in all stages of manufacture, using drawings, instructions, or other relevant documents;
7.4. before, during and after manufacture and the checks to be carried out in the early stage, the frequency izmēģ and equipment used.
8. The notified body shall carry out the audit of the quality system to determine whether they comply with this annex 7 requirements referred to in paragraph and shall adopt, in respect of quality systems that implement the harmonized standards, meets these requirements. Examination (audit) of at least one person with experience of assessments of the technology concerned. The evaluation procedure shall include an inspection on the manufacturer's premises. The decision shall contain the conclusions of the inspection and a reasoned assessment, and decision is notified to the manufacturer after the last inspections.
9. the authority which has approved the quality system, the manufacturer shall inform on all planned changes in the system. The notified body shall evaluate the proposed changes and verify whether after these changes the quality system still complies with section 7 of this annex. The decision shall contain the conclusions of the inspection and a reasoned assessment, and decision is notified to the manufacturer.
10. the notified body the manufacturer gives permission to carry out all the necessary inspections and shall provide it with all necessary information, including: 10.1. quality system documentation;
10.2. data provided for part of the quality system relating to manufacture of medical devices.
11. the Notified Body shall periodically carry out appropriate inspections and assess how the manufacturer applies the approved quality system, and send their produce to the assessment report. The notified body may pay unannounced visits to the manufacturer take a look and send him a message about this.
12. the Notified Body for other notified bodies in the European Union shall communicate all relevant information on atņemtaj issued, refused or the quality system authorization.
Health Minister g. Smith 16. attachment Cabinet 2 august 2005 No. 581 of the provisions on medical devices intended for special purposes (90/385-6) (1). the manufacturer or his authorized representative on medical devices made to order, make up the Act. Act 2 of this annex shall include the information referred to in paragraph.
2. The Act on medical devices made to order, are the following: 2.1 description of the medical device;
2.2. the document which certifies that the medical device is intended only for a specific patient (the patient's first and last names);
2.3. the prescribing doctor's name and, if necessary, the hospital's name;
2.4. the nature of the medical device described in the recipe;
2.5. the document which certifies that the device complies with the essential requirements (if necessary, indicating which essential requirements of a medical device only partially, as well as such derogations justification).
3. the manufacturer, health statistics and medical technologies State agency needs keep custom-made medical devices documentation that allows you to understand the design, manufacture and operation (also for action), so as to allow assessment of conformity with the Cabinet 2 august 2005 No. 581 of the provisions "of the registration of medical devices, conformity assessment, distribution, operation and technical monitoring procedures".
4. The manufacturer shall take all measures necessary to ensure that the products manufactured conform to this annex referred to in paragraph 2, set out in the documentation. The manufacturer can provide the right health statistics and medical technologies State agency or a notified body, if necessary, during the audit to assess the effectiveness of these measures.
Health Minister g. Smith 17. attachment Cabinet 2 august 2005 No. 581 of the provisions of the EC declaration of conformity (98/79-3) 1. EC declaration of conformity is the procedure whereby the manufacturer, or his authorised representative who fulfils this annex 2., 3., 4., 5 and 6 above, and declares that the products concerned conform to the Cabinet of Ministers of 2 august 2005 No. 581 of the provisions of the "medical device registration , conformity assessment, distribution, operation and technical monitoring procedures "(hereinafter rules) requirements that apply to them. The manufacturer of the device shall be marked with the CE marking.
2. the manufacturer shall prepare this annex referred to in paragraph 3 of the technical documentation and ensure that the manufacturing process of this annex are complied with paragraph 4 referred to the principles of quality assurance.
3. The technical documentation shall assess the compliance of the product requirements. The technical documentation shall include: 3.1 General description of the product (also planned variants);
3.2. the quality system documentation;
3.3. development of information (including information about the parameters of the base), the medical device parameters and operating constraints, manufacturing methods, in relation to instruments, design drawings, diagrams of parts, sub-assemblies composition, circuit, etc.;
3.4. If a medical device is the organ tissues of human origin or substances derived from such tissue, information on the origin of such material, and the circumstances under which it was collected;
3.5. the descriptions and explanations necessary for the understanding of the parameters referred to in this paragraph, drawings and charts, as well as the operation of the product;
3.6. results of risk analysis and, if necessary, a list of the standards applied and a description of the solutions adopted, the essential requirements if the standards are not applied in full;
3.7. for sterile products or special microbiological State or State of cleanliness for existing products, the description of the procedures used;
3.8. development and results of the checks carried out;
3.9. If intended use for medical devices are used in combination with other medical devices, the proof that, when combined with any medical device, which parameters are specified by the manufacturer, it shall comply with the essential requirements;
3.10. the reports on the tests;
3.11. adequate information on performance evaluation indicating the activities requested by the manufacturer and is based on the measuring system called ATI (if any), as well as information on the reference methods, the reference materials, the known reference values, the accuracy and measurement units used (following information compiled from studies carried out in clinical environments or other appropriate environment or a drop in the biographical reference);
UR3.12.eti ķet and instructions for use of the samples;
3.13. the results of the stability studies.
4. the manufacturer shall take all measures necessary to ensure that the manufacturing process and respect the principles of quality assurance laid down in respect of the products manufactured.

5. the quality system shall apply to: 5.1 organizational structure and responsibilities;
5.2. the manufacturing processes and systematic quality control of production;
5.3. the funds of the quality control system.
6. The manufacturer shall Institute and keep up to date a procedure whereby, after completion of production systematic review with the manufactured medical devices related experience and to implement appropriate means to apply any necessary corrective actions, taking account of the characteristics of the product and the risks involved. Manufacturers will be obliged to inform the competent authorities of the following happened: UR6.1.par ating parameter or the medical device malfunction or deterioration, as well as any inadequacy in the labelling or the package instruk tion, directly or indirectly, might lead to or have led to the patient or user or other persons death or a serious deterioration in his State of health;
UR6.2.par any technical or medical reason connected with the characteristics or the medical device operation of the same type by the manufacturer of the medical device is constantly removed from circulation due to this annex referred to in point 6.1 below.
7. for devices for self-testing the manufacturer shall lodge an application notified body for checking the design. The application allows you to understand the following structure and ensure its compliance with the requirements of the rules. The application shall comprise: 7.1. reports on the tests and, if necessary, amateur research results;
7.2. information showing the suitability of a medical device, in view of its dedicated self-inspection function;
7.3. information provided in conjunction with medical device on its label and in the instructions for use.
8. the Notified Body shall examine the application and, if the product meets the requirements of the rules, issue an EC design-examination certificate. The notified body may request further tests or proof to allow assessment of conformity with the design requirements of the rules. The certificate contains the conclusions of the examination, conditions for its validity, the necessary data for identification of the approved design and, if necessary, the function of the product description.
9. the body which issued the EC design-examination certificate, the applicant shall be informed of any significant change in the approved design. Each time the changes to the approved design could affect conformity with the essential requirements or the prescribed conditions for use of the product, the approved body which issued the EC design-examination certificate. Additional confirmation is EC design-examination certificate.
Health Minister g. Smith annex 18. Cabinet 2 august 2005 Regulations No 581 EC type-examination (98/79-5) 1. EC type-examination is the part of the procedure whereby a notified body ascertains and attests that the products covered, gi complies with the relevant cabinet 2 august 2005 No. 581 of the provisions "of the registration of medical devices, conformity assessment, distribution, operation and technical supervision procedures" (hereinafter referred to as the rules).
2. The application for EC type-examination of the notified body shall be lodged by the manufacturer or by his authorized representative. The application shall contain: 2.1. name and address of the manufacturer, his authorised representative, as well as the name and address of the representative, if the application is lodged;
2.2. this annex referred to in paragraph 3 of the documentation necessary to evaluate how a particular product (hereinafter type) meet the requirements of the rules;
2.3. the notice in writing that such application has not been lodged with any other notified body in other Member States of the European Union.
3. The applicant shall refer the notified body type, and the notified body may, if necessary, to request other samples.
4. EC type-examination documentation provides a clear picture of the medical device design, manufacture and operation. Documentation shall specify, in particular: 4.1 General description of the type (including all planned variants);
4.2. Annex 17 rules 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 3.10, 3.11, 3.12 and 3.13 documentation referred to;
4.3. for devices for self-testing: Annex 17 rules of the information referred to in paragraph 6.
5. The notified body EC type-examination process: 5.1. examine and assess the documentation and verify that the type has been manufactured in accordance with that documentation;
UR5.2.re ģistr the articles drawn up in accordance with the applicable stan darts, as well as items that will completely the design does not take into account the relevant standards referred to;
5.3. carry out the appropriate inspections and the tests necessary to check that the solutions adopted by the manufacturer meet the essential requirements if the standards have not been applied;
5.4. do or requested to perform the inspections and tests that you need mass to see whether, where the manufacturer has chosen to apply the relevant standards, the horse actually applied;
5.5. agree with the applicant on the place where the necessary examinations and tests will be carried out.
6. Where the type meets the requirements of the rules, the notified body shall issue an EC type-examination certificate. The certificate shall state the name and address of the manufacturer, conclusions of the examination, the results, the conditions for validity of the certificate and the information necessary to identify the approved type. The relevant parts of the documentation attached to the certificate, in the form of an annex, and one copy of it stored in the notified body.
7. where a producer has obtained information about changes to the pathogen and markers of infections to be tested (in particular the consequence of biological complexity and variability), he shall immediately inform the notified body. The manufacturer shall inform the notified body whether such changes might affect the medical device used for in vitro diagnosis, action.
8. If the changes may affect conformity with the essential requirements or medical conditions prescribed for use of the device, approved further changes to the medical device approved by the body which issued the EC type-examination certificate. The applicant shall inform the authority which granted the EC type-examination certificate of any such approved medical device changes. The new certification is the original EC type-examination certificate.
9. other Member States of the European Union notified bodies may obtain EC type-examination certificate, or a copy of the annex. The certificate supplement is available to these bodies on reasoned application, for it has been informed by the manufacturer.
Health Minister g. Buchanan 19. Annex Cabinet 2 august 2005 No. 581 of the provisions of the EC declaration of conformity (complete quality assurance system – 98/79-4) 1. Manufacturer in accordance with this annex 3, 4 and 5 shall apply the quality system approved for the design of medical devices, manufacture and final inspection and subject to this annex referred to in point 8 and 15 of this annex of the audit. 16. and 17. monitoring referred to in paragraph 1. For Cabinet 2 august 2005 No. 581 of the provisions "of the registration of medical devices, conformity assessment, distribution, ESA pluatācij and technical monitoring procedures" (hereinafter rules) of the annex 2 list of articles in the medical devices manufacturer comply with this annex 10, 11, 12, 13, 14, 18 and 19 above.
2. the Declaration of conformity is the procedure whereby the manufacturer fulfils the annex referred to in paragraph 1, shall ensure and declare that the medical device meets the requirements of the rules applicable to them. The manufacturer must affix the CE marking and draws up a declaration of conformity covering the medical device concerned.
3. the manufacturer shall provide the notified body application request an assessment of his quality system. The application shall include: 3.1 the manufacturer's name, address and any additional sites covered by the quality system;
3.2. adequate information on the medical device or the category covered by the procedure;
3.3. a written declaration that the application in respect of the quality system relating to medical devices, not been lodged with any other notified body in other Member States of the European Union;
3.4. documentation on the quality system;
3.5. the manufacturer's commitment to fulfil the obligations imposed by the approved quality system were high;
3.6. manufacturer's commitment to maintain the approved quality system adequate and efficacious enough;
3.7. the manufacturer's commitment to implement and regularly update procedures, as well as the systematic review after completion of the production manufactured devices related experience and to implement appropriate means to apply any necessary corrective and notification in accordance with the provisions of Annex 17.

4. The quality system must ensure that at all stages, from design to final inspection in the medical device meets the requirements of those regulations applicable to them. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies and procedures (for example, in high quality security system of programmes, quality plans, quality manuals and quality records).
5. Quality System Description: 5.1 the quality objectives;
UR5.2.uz ņēmējdarbīb of the Organization, in particular: 5.2.1 the organizational structures, the responsibilities of the joint powers and organizer for the medical devices development and manufacturing quality;
5.2.2. the efficient operation of the quality system management techniques and the ability to achieve the desired development and quality of the medical device, as well as the medical control of devices which fail to conform;
5.3. procedure of medical equipment for monitoring and verifying the design, notably including: 5.3.1. a general description of the medical device, including any variants planned;
5.3.2. the provisions of Annex 17 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 3.10, 3.11, 3.12 and 3.13 documentation referred to;
UR5.3.3.pa of the špārbaud in the case of rule 17 of the annex referred to in point 6.1 information;
5.3.4. the development of the method used and the control and verification of the process, as well as regular measures that will be taken in the development of medical devices;
5.4. the inspection and quality assurance techniques at the manufacturing stage, in particular: 5.4.1. processes and procedures which will be used (in particular as regards sterilization);
5.4.2.ar purchase of related procedures;
5.4.3. the product identification procedures drawn up and kept up to date in all stages of production, from drawings, specifications or other relevant documents;
5.5. the tests and trials carried out before, during and after manufacture, the frequency and the equipment to be used (must be able to properly consult equipment calibration).
6. the manufacturer must take the necessary control measures and tests in accordance with the latest technical developments. Control measures and izmēģ in the early stage refers to the manufacturing process, as well as individual honey, raw materials and devices or cīnisk each manufactured batch of medical devices characterization.
7. the provisions of annex 2 to try out A list of the medical device, the manufacturer shall follow the latest information available, particularly as regards the biological complexity and variability of the sample to be checked in conjunction with the medical device in vitro.
8. the Notified Body shall examine the quality system to determine whether it meets this annex (4) and (5) the requirements referred to in, and accept that the quality system that uses the relevant harmonised standard meets these requirements. The test will involve at least one person with experience in the evaluation of the technology concerned. The assessment procedure includes verification of the manufacturer's premises, in duly justified cases, the manufacturer's suppliers or subcontractors premises to inspect the manufacturing processes. The decision shall contain the conclusions of the inspection and a reasoned assessment, and decision is notified to the manufacturer.
9. The manufacturer shall inform the body which approved the quality system informed of any substantial changes in the relevant quality system or product range. The said authority shall evaluate the changes proposed and verify whether after these changes the quality system still meets the 4 and 5 of this annex to the requirements of paragraph, and notify its decision to the manufacturer. The decision shall contain the conclusions of the inspection and a reasoned assessment.
10. with regard to the provisions of annex 2 contained in the list of medical devices manufacturer CAI additional obligations imposed in accordance with this annex 3, 4 and 5 shall be submitted to the notified body shall examine the application development documentation pertaining to medical devices, which he plans to make.
11. in paragraph 10 of this annex in the application referred to in the description of the relevant MEDA cīnisk device development, manufacture, installation and operation, and includes documents that are necessary to determine whether a medical device meets the requirements of these regulations.
12. the Notified Body shall examine the application and, if the product meets the relevant conditions shall issue the ERS with an EC design-examination certificate. The notified body in respect of the application may require additional tests or proof to allow assessment of conformity with the requirements of the rules. The certificate shall contain the opinions, validity checks, identification of the approved design data necessary for information and, if necessary, a medical device for the purpose.
13. If the modifications to the approved design in may affect the conformity with the requirements, or should a CAI medical device intended conditions of use, the changes to the approved design separately approved by the body that issued the EC design-examination certificate. The applicant shall inform the body which issued the EC design-examination certificate of all modifications to the approved design. The additional approval shall be issued as an annex to EC design-examination certificate.
14. the manufacturer shall inform the notified body, if he has acquired the information on pathogens and infectious markers to be tested (in particular of biological complexity and variability in the results). The manufacturer shall inform the notified body whether such changes may affect the medical device used for in vitro diagnostic, activity.
15. the manufacturer gives the Authority notified the authorisation to carry out all the necessary inspections and shall provide it with all necessary information, including: 15.1. documentation on the quality system;
15.2. the data stipulated in the part of the quality system relating to design;
15.3. the data stipulated in the part of the quality system relating to manufacture.
16. the Notified Body must periodically carry out appropriate inspections and assessments to ensure that the manufacturer applies the approved quality system and supply the manufacturer with an assessment report.
17. the Notified Body may pay unannounced visits to the manufacturer. During such visits the notified body may, if necessary, carry out or ask for tests in order to check that the quality system is working properly. It sends the inspection report to the manufacturer (if the test is carried out – also check message).
18. with regard to the provisions of annex 2 contained in the list of medical devices manufacturer CAI immediately after the control measures and the completion of the checks sent to the Authority notified the relevant reports on the tests carried out on the manufactured medical devices or each batch of medical equipment. The manufacturer further prepares medical equipment produced or batch samples which are available to the notified body in accordance with the conditions laid down in that annex, and details on the modalities.
19. the manufacturer of the medical device can be put into circulation unless the term for which you have an agreement, but not later than 30 days after the date of receipt of the samples, the notified body shall notify the manufacturer, not another decision (also on the validity of the certificates issued by the conditions).
Health Minister g. Smith 20. Annex Cabinet 2 august 2005 No. 581 of the provisions of the EC declaration of conformity (production quality assurance – 98/79-7) (1). the manufacturer shall apply the quality system approved for the manufacture of medical devices, and perform a full inspection in accordance with this annex 3, 4, 5, 6, 7 and 8, and the producer covered by this annex, the monitoring referred to in paragraph 9.
2. the Declaration of conformity is the part of the procedure whereby a manufacturer who fulfils this referred to in paragraph 1 of the annex, ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and the Cabinet 2 august 2005 No. 581 of the provisions "of the registration of medical devices, conformity assessment, distribution, ESA pluatācij and technical monitoring procedures" (hereinafter rules) requirements that apply to them. The manufacturer must affix the CE marking and draws up a declaration of conformity covering the medical device concerned.
3. the manufacturer shall provide the notified body application request an assessment of his quality system. The application shall include: 3.1 of annex 19 of the provisions referred to in paragraph 3 of the documentation and apņemš;
3.2. technical documentation on the types approved and the EC type-examination certificate.
4. application of the quality system shall ensure that the electronic check in the medic device conform to the type described in the EC type-examination certificate.

5. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written statement of the strategy and procedures. This provides you with the quality system documentation shall permit uniform interpretation of the quality policy and procedures (such as quality programmes, plans, manuals and quality records).
6. Quality system description in detail: 6.1 the manufacturer's quality objectives;
UR6.2.uz ņēmējdarbīb organization: 6.2.1. organisational structures, the responsibilities of the personnel and organizational authority, relating to the manufacture of medical devices;
6.2.2. the methods of monitoring the efficient operation of the quality system and the ability to achieve the desired quality of product, as well as the medical control of devices which fail to conform;
6.3. the inspection and quality assurance techniques at the manufacturing stage, including: 6.3.1. processes and procedures which will be used (in particular as regards sterilization);
6.3.2.ar purchase of related procedures;
6.3.3. the product identification procedures drawn up and regularly renewed at every stage of manufacture, from drawings, specifications or other relevant documents;
6.4. the tests and trials carried out before, during and after manufacture, the frequency and the equipment used.
7. the Notified Body shall examine the quality system to determine whether it meets this annex 4, 5 and 6 of these requirements, and shall adopt, in respect of quality systems that implement the relevant harmonised standard meets these requirements. The test will involve at least one person with previous experience in the assessment of the technology concerned. The evaluation procedure includes a check of the manufacturer's premises, in duly justified cases, the manufacturer's suppliers or subcontractors premises to inspect the manufacturing processes. The decision shall contain the conclusions of the inspection and a reasoned assessment, and decision is notified to the manufacturer.
8. The manufacturer shall inform the body which approved the quality system informed of any substantial changes to the quality system. The notified body shall evaluate the proposed changes and verify whether after these changes the quality system still meets the present annex 4, 5 and 6. The decision shall contain the conclusions of the inspection and a reasoned assessment, and decision is notified to the manufacturer.
9. Monitoring shall be carried out in accordance with the provisions of annex 19.15, 16, 17 and 18.
10. with regard to the provisions of annex 2 list A medic in niskaj contained in the devices verification means that: 10.1. without delay after the conclusion of the controls and tests the relevant notified body sent reports on the tests carried out on the manufactured medical devices or each batch of medical equipment. The manufacturer prepares the future production of medical devices or medical device batch samples available to the notified body, in accordance with the conditions and the detailed data, previously agreed;
10.2. the manufacturer of the medical device can be put into circulation unless the time limit for which a prior agreement, but not later than 30 days after the receipt of the samples, the notified body shall notify the manufacturer, not another decision (also on the validity of certificates issued).
Health Minister g. Smith 21. attachment Cabinet 2 august 2005 Regulations No 581 EC verification (98/79-6) 1. EC verification is the procedure whereby the manufacturer or its authorised representative ensures and declares that the products covered by this annex, paragraph 6 of the procedure, conform to the type described in the EC type-examination certificate and with the relevant cabinet 2 august 2005 No. 581 of the provisions of the "medical device registration , conformity assessment, distribution, ESA pluatācij and technical supervision procedures "(hereinafter referred to as the rules).
2. the manufacturer shall take all measures necessary to ensure that the manufacturing process produces products which conform to the type described in the EC type-examination certificate and the requirements of the rules.
3. the manufacturer shall, before the start of manufacture, prepare documents mentācij, which sets out the course of manufacture of products (in particular as regards sterilization), as well as, if necessary, apply jamīb of the materials used, and determine the procedures required under the technical achievements of the ERS. The progress of work and to conditions imposed in order to ensure uniformity of production compare and conform to the EC type-examination certificate check pattern and the relevant requirements of the rules.
4. To the extent that for certain aspects the final testing according to section 9.3 of this annex is not appropriate, the manufacturer, develop an adequate process testing, monitoring and control methods, and the notified body confirms these methods. 19. The provisions of annex 15, 16, 17 and 18, these conditions apply to the abovementioned approved procedures.
5. the manufacturer must undertake to Institute and keep up to date a systematic procedure to review after completion of production with the manufactured medical devices related experience and to implement appropriate means to apply any necessary corrective and notification in accordance with rule 17, paragraph 6 of the annex.
6. the Notified Body shall, having regard to paragraph 4 of this annex nosacīj referred to must, by carrying out appropriate checks in order to verify the conformity with the requirements of the rules, verifying and controlling each article in accordance with paragraph 8 of this annex, or statistically verifying and controlling products in accordance with this paragraph 9 Add Kuma (according to the manufacturer's decision). Implementing the statistical verification in accordance with paragraph 9 of this annex, the notified body shall decide whether statistical procedures to be applied in respect of the lot or batch of a separate check. Such a decision shall be taken, in consultation with the manufacturer.
7. To the extent that statistical tests and trials are inadequate, tests and trials may be carried out at random, provided that such procedure in conjunction with measures to be taken in accordance with paragraph 4 of this annex, provides the same level of compliance.
8. verification by examination and testing of every product, means that: 8.1. every product is examined individually and to certify a product bearing this type-examination EC type described in the certificate and the requirements of the rules, take the tests in accordance with the relevant standards or equivalent test;
8.2. the notified body shall be affixed to each approved product identical number fikācij, as well as draw up a written certificate of conformity relating to the tests carried out.
9. statistical verification means that: 9.1 the manufacturer presented products manufactured of homogeneous lots;
After each batch is 9.2.no where having one or more random samples. Check the products that make up the sample, and the appropriate test for you according to the relevant standards or, if necessary, equivalent tests, to check the conformity of the type-examination EC type described in the certificate and the relevant requirements of the rules to determine whether to accept or reject the batch;
9.3. statistical control of products will be based on attributes, entailing a sampling schemes with operational characteristics which ensure a high level of safety and performance according to the State of the art. Sampling schemes drawn up according to the harmonized standards, taking into account the specific nature of the product categories;
9.4. If the batch is accepted, the notified body shall affix to each product's identification number and draw up a written certificate of conformity relating to the tests carried out. All products in the batch (except any existing product samples that do not meet requirements) may be placed on the the Ziba in Rev. If a lot is rejected, the notified body shall take appropriate measures to prevent the placing in circulation of the party. In the event of frequent rejection of lots the notified body may suspend the statistical verification. The manufacturer may affix the identification number of the production process only with the permission of the notified body.
Health Minister g. Smith 22. Annex Cabinet 2 august 2005 No. 581 of rules and procedures with respect to performance evaluation for medical devices (98/79-8) 1. In regard to performance evaluation for medical devices, the manufacturer or his authorised representative shall draw up the statement containing the annex referred to in paragraph 2, the information, and ensure compliance with the relevant Cabinet of Ministers of 2 august 2005 No. 581 of the provisions of the "medical device registration , conformity assessment, distribution, operation and technical supervision procedures "(hereinafter referred to as the rules).
2. The notification shall contain: 2.1 the medical device description;
UR2.2.nov valuation of the plan for the purpose, scientific, technical or medical grounds, scope of the assessment and the number of medical devices;
2.3. laboratory or other list of institutions participating in the evaluation;

2.4. starting date and scheduled duration for the evaluations, for devices for self-testing, the professionals involved-not the user location and number;
2.5. message stating that the medical device meets the requirements of the rules concerned (except the aspects covered by the evaluation, and aspects that are particularly highlighted in the notice) and that every precaution has been taken to protect the patient, user, or other individual health and safety.
3. the manufacturer, health statistics and medical technologies State Agency shall also undertake to keep available for the documentation allowing an understanding of the design, manufacture and performances of the product (including the expected performances), so as to allow assessment of conformity with the requirements of the rules. The said documentation shall be kept for at least five years after completion of the evaluation.
4. the manufacturer shall take all measures necessary to ensure that the products manufactured conform to this annex referred to in paragraph 2 of the documentation.
Health Minister g. Smith 23. attachment Cabinet 2 august 2005 Regulations No 581 by medical devices safety groups in the UR1.1.dro security group includes the following medical devices: 1.1. anesthesia inhalation anaesthesia equipment;
1.2. ventilatory equipment (excluding manually operated equipment);
1.3. central medical gas supply systems;
1.4. external heart stimulation machines;
1.5. defibrillator;
1.6. the medical equipment of electric shock;
1.7. elektronarkoz (elektromieg);
1.8. lāzerķirurģisk and laser equipment;
1.9. fotokoagulācij equipment;
1.10. the high-frequency Electrosurgical equipment;
1.11. elektroterapij high-frequency machines;
1.12. krioķirurģij equipment;
1.13. lithotripsy equipment;
1.14. artificial circulatory devices;
1.15. transfuzioloģij equipment;
1.16. hypothermia equipment;
1.17. barokamer and other equipment increased or intermittent pressure to use more than half of the body;
1.18. hidrokolonterapij device;
1.19. the iromiostimulācij equipment (therapeutic and diagnostic);
1.20. elektroencefalogrāfij equipment;
1.21. the high pressure injection equipment;
ūzij and UR1.22.inf perfusion pumps;
1.23. intrakardiāl study (fonokardiogrāfij, ECG and other intrakardiāl examinations);
1.24. asinsplūsm magnetic and ultrasonic testing equipment;
1.25. the irradiation equipment irradiation of the whole body (ultraviolet, infrared, quantum, magneto and other radiation);
1.26. sterilization and disinfection equipment with increased pressure (fixed installations, including an autoclave);
1.27. elektroapsildām bed and other heating systems the entire body;
1.28. incubator (stationary and mobile);
1.29. dialysis equipment, 1.30. rentgendiagnostik equipment;
1.31 CT equipment;
1.32. angiography equipment;
1.33. mammography equipment;
1.34. other rentgeniekārt (including osteodensitometr);
1.35. the linear accelerators (distance or external irradiation equipment);
1.36. brahiterapij equipment;
1.37. other medical equipment for ionizing radiation or radioactive substances;
1.38. magnetic resonance equipment;
1.39. ultrasonic therapeutic and nostisk equipment into (including ultra sound osteodensitometr);
1.40. the other therapeutic and diagnostic equipment for multimodulār, which is a module that serves as this annex 1.1., 1.2., 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 1.10, 1.11, 1.12, 1.13, 1.14, 1.15., 1.16, 1.17, 1.18, 1.19., 1.20, 1.21, 1.22, 1.23.., 1.24, 1.25, 1.26.., 1.27, 1.28, 1.29.., 1.30, 1.31, 1.32., 1.33, 1.34, 1.35.., 1.36 1.37 1.38, 1.39, or. referred to medical devices , and other medical devices, where the producer or conformity assessment documents in a particular medical device has the following qualified.
UR2.2.dro security group includes the following: UR2.1.zob the medical device medical equipment (if the manufacturer's documents, they are not qualified as Group 1 safety devices);
2.2. physical therapy equipment, not the security group 1;
2.3. the irradiation equipment (ultraviolet, infrared and other radiation) with local effects;
2.4. using endoscopic equipment;
2.5. patient monitors;
2.6. electrocardiograph;
2.7. functional diagnostic equipment;
2.8. sterilization and disinfection equipment (small equipment, including an autoclave);
2.9. medical aukstumiekārt including special medical refrigerators;
2.10.in vitro diagnostic analyzers;
2.11. ophthalmological equipment, if its not 1. Security Group;
2.12. technical AIDS (electromechanical measuring devices fitted and AIDS);
2.13. any other active therapeutic and diagnostic medical devices, if they are not included in the security group 1;
2.14. medical equipment (energy-measuring devices).
UR3.3.dro security group includes all other medical devices that are not included in the 1 and 2 security group.
Health Minister g. Smith