Key Benefits:
See the copyright notice Conditions of use .
In accordance with the decision of the Parliament:
The purpose of this law is to maintain and promote the safety of medical equipment and supplies and their use.
This law implements Council Directive 90 /385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, hereinafter referred to as: Aimd Directive , Council Directive 93 /42/EEC on medical devices (hereinafter referred to as ' the The md Directive , and Directive 98 /79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices, hereinafter referred to as: The IVD Directive And subsequent amendments thereto.
This law shall apply to the design and manufacture of medical equipment and accessories and their accessories, as well as to the assembly of operational packages and systems. In addition, the law applies to the placing on the market and for the purposes of sterilisation, commissioning, installation, maintenance, professional use, marketing and distribution. The application of the law to the manufacture of a health care unit for own equipment is laid down in Chapter 5.
This law shall not apply to:
(1) blood cells, blood cells, blood plasma, blood products and equipment containing them at the time of the placing on the market of the device;
(2) organs, tissues and cells of human origin; and
(3) animal organs, tissues and cells, and not micro-organisms; however, the law shall apply where the use of a medical device or article is used for the use of animal tissue which has undergone , or of products derived from tissues derived from the animal, which are unviable.
By way of derogation from paragraph 1, the law shall apply, however:
(1) in vitro diagnostic medical devices containing tissues or cells derived from or derived from human origin; and
(2) a medical device and article containing, as an integral part, a substance which, if used separately, may be considered as a medicinal product or as a constituent of a medicinal product derived from human blood or plasma, and which may be used by a device or article In addition to the main effect, to have a medicinal effect on the human body.
If a device or article for the administration of a medicinal product is, in combination with a medicinal product, a single product intended solely for use in this assembly and cannot be reused, the medicinal product shall be (185/1987) Provisions. However, the safety and performance of a device or article in a combination shall meet the requirements laid down in this Act.
In addition, the control of the use of radiation equipment, radioactive materials and radiation in the field of radiation safety is subject to radiation law (1892/1991) .
They're prescriptions for medical prescriptions. When assessing whether a product falls within the scope of the medicinal product or of this law, account shall be taken, in particular, of the main mode of action of the product. In case of doubt, where the product is capable of responding to the definition of both a medicinal product and a medical device and article, the product shall be applied primarily to medicinal products.
Where a medical device other than in vitro diagnostic medical equipment is also a machine within the meaning of machinery safety legislation, the device shall also comply with the health and safety requirements of that legislation; and The essential requirements for safety when they are more detailed and non-compliance with the essential requirements provided for by this law would jeopardise the safety of the health service.
Where the manufacturer has intended to be used by a device or article as a personal protective device or as a medical device or article, it shall also comply with the health and safety requirements of personal protective equipment.
The Law does not apply to cosmetic products (2011) Of the products.
For the purposes of this law:
(1) Health care device An instrument, equipment, instrument, software, material or other device or equipment used in isolation or in combination, intended for human use by the manufacturer:
(a) diagnosis, prevention, monitoring, treatment or mitigation of the disease;
(b) diagnosis, observation, treatment, alleviation or compensation of disability or disability;
(c) examination, replacement or modification of anatomy or physiological function; or
(d) the regulation of fertilisation;
(2) Active implantable health equipment By means of an energy source or a force other than direct human body, by force or force, which is intended to be permanently installed, in whole or in part, surgically or by any other medical method The human body or the medical procedure for the natural opening of the body and which is intended to be left in place after the procedure;
(3) In vitro diagnostics By means of a medical device Reagent, reagent solution, calibrator, reference material, test pack, instrumentation, device, equipment and system that is used alone or in combination with others and whose manufacturer has intended to be used by the human body Outside (in vitro) studies, the sole or main purpose of which is to obtain information on the human person on the basis of the samples taken:
(a) physiological or pathological conditions;
(b) congenital malformation;
(c) the safety of the samples and their compatibility with the recipient; or
(d) the impact of management measures;
(4) For self-testing Within the meaning of In vitro diagnostic medical devices intended by the manufacturer for use by a non-health professional;
(5) Personalised use of The device To a single designated patient in accordance with the (559/1994) A device manufactured in accordance with the written provision of a healthcare professional; however, a device manufactured for individual use shall not be regarded as a continuous or serial-production device which has been modified; On the basis of specific needs identified by a doctor or other professional user;
(6) Additional device The instrument, equipment, instrument, material or other device or equipment which its manufacturer has specifically intended to use with a particular health device to enable the device to be used by the manufacturer, The intended use;
(7) With a disposable device A health care device specified by the manufacturer for use only once for one patient;
(8) Performance assessment equipment In vitro diagnostic healthcare device, intended by the manufacturer for one or more performance assessment studies in a clinical laboratory or in any other compartment outside the manufacturer's premises;
(9) Clinical evaluation The assessment carried out by the manufacturer on the basis of clinical data confirming that the equipment's characteristics and performance are in accordance with the requirements under normal conditions of use of the device; the clinical evaluation shall include an assessment of adverse reactions and The acceptability of the benefit balance;
(10) The device for clinical trials A health care device intended to check the performance of the device and to determine and evaluate undesirable side effects in an appropriate clinical environment;
(11) Clinical data The safety or performance data obtained on the basis of clinical use of the healthcare equipment; the data shall be derived from:
(a) one or more clinical trials on the device concerned;
(b) a similar device for which the equivalence with the relevant device may be demonstrated for one or more clinical trials or other studies which have been reported in scientific literature; or
(c) any published or unpublished reports of other clinical experience of the relevant or similar device with the equivalent of the device in question;
(12) By a clinical examination Research on humans to determine, assess or verify the intended use and characteristics of a healthcare device;
(13) Manufacturer Any natural or legal person responsible for the design, manufacture, packaging and labelling of a healthcare device to place the device on the market for its own name; these actions may also be carried out by another manufacturer , the obligations imposed on manufacturers shall apply equally to a natural person and to a legal person who collects, packages, processes, completely refurbish, retreats or marks one or more of the finished products or gives them Intended use as a health care device for its purpose On the market for its own name;
(14) Authorised representative Any natural or legal person established within the territory of the European Union, who, as designated by the manufacturer, is acting on behalf of the manufacturer and where the authorities and others may turn to the manufacturer instead of the manufacturer; In matters relating to the obligations laid down in the obligations of the Member State concerned;
(15) Operator Any natural or legal person responsible for the importation of a health care device in return for consideration, whether in return for sale, hire or other distribution, or, in professional terms, to install or maintain medical equipment;
16) Health care unit On the status and rights of the patient (785/1992) The health care unit referred to in paragraph 4;
(17) By a professional user :
(a) the health care unit referred to in Article 2 (4) of the Law on the status and rights of the patient, (1301/2014) in Article 14 And the Law on the Special Care of Persons with Disabilities, (519/1977) § 9 The special management unit for which it is intended; (30/04/2013)
(b) a healthcare professional in accordance with the law on health care professionals, who, when performing the profession, uses or dispose of a healthcare device; or
(c) any other natural or legal person whose activity or profession is carried out in accordance with points (a) to (c) of paragraph 1, or which, in those tasks or in the course of teaching, uses or continues to dispose of Medical devices;
(18) Use intentionally The use of the health care device on the label of the manufacturer, in the instructions for use or in the promotional material;
19) Placing on the market The placing on the market of a medical device for the first use of a device or without compensation for the distribution or use of the equipment in the territory of the European Union, whether new, fully refurbished or reprocessed; The performance of the device shall not be considered as a means of carrying out a clinical examination or a performance evaluation study of in vitro diagnostic equipment;
20) Introduction The stage at which the health care device is available to the end user and ready for use for the first time in accordance with its intended use within the European Union;
21) The rating regulation A breakdown of the healthcare equipment for the purpose of assessing conformity with product categories;
22) Reprocessing The manufacture of equipment in which the medical device specified by the original manufacturer as a single-use medical device is treated after use so that it can be reused for its original purpose; and
23) The notified body A body designated by the Member State of the European Union and notified to the European Commission, which is entitled to carry out conformity assessments.
Healthcare appliances shall also be regarded as the software necessary for the proper operation of the device or article, intended by the manufacturer for one or more of the purposes referred to in paragraph 1 (1). The functioning of the health care device may be promoted by pharmacological, immunological and metabolic means, provided that the principal intended effect of the device is not achieved in this way.
The healthcare appliance must meet the relevant essential requirements. For active implantable health equipment, the requirements of Annex I to the AIMD Directive, in vitro diagnostic devices, are subject to the requirements of Annex I to the IVD Directive and to other equipment in accordance with the MD Directive Requirements of Annex I.
The health care device fulfils the essential requirements when it is designed, prepared and equipped in accordance with the relevant national standards, where these standards have been adopted in accordance with harmonised standards for: The references are published in the Official Journal of the European Union. The essential requirements may also be met other than by complying with the standards referred to above.
The device shall be suitable for its intended use and shall, when used in accordance with its intended use, achieve its intended functionality and performance. The appropriate use of the device shall not unnecessarily endanger the health or safety of the patient, the user or any other person.
The Agency for Social Affairs and Health may give more detailed provisions on the content of the essential requirements.
On the basis of its characteristics, health care equipment shall be broken down into product categories I, II (a), IIb and III and in vitro diagnostic medical devices for equipment for the purposes of List A and B, Equipment, equipment for performance assessment and other equipment. The categories of equipment are determined on the basis of the MD and IVD Directives. The Agency for Social and Health Authorisation and Control may provide more detailed provisions on the determination of the categories of equipment.
A manufacturer or an authorised representative established in the European Economic Area may place a health service on the market when the device meets the requirements of this law.
A health care device placed on the market shall be put into service when properly delivered, installed, maintained and used in accordance with this law.
The ce marking the manufacturer shows that the health service satisfies the relevant essential requirements. When placing the device on the market, it shall bear the ce marking.
By way of derogation from the provisions laid down in paragraph 1, the CE marking shall not be equipped with a device manufactured for individual use, a package of measures, a system, a performance assessment device and a health care unit. A device manufactured by equipment. In addition, the manufacturer of the sterilisation service shall not affix the ce marking to the device.
Where a medical device is also covered by other legislation which contains provisions on the ce marking, the label shall indicate that the apparatus is also in conformity with those other provisions.
The Agency for Social and Health Authorisation and Control may provide more detailed provisions on the use of ce marking in healthcare equipment.
The healthcare appliance may be placed to be seen, even if it does not comply with the essential requirements referred to in Article 6, where a clear indication has been shown that the device may not be placed on the market or put into service before it has been Compliance. A in vitro diagnostic device which is set to be seen and which does not meet the essential requirements shall not be used for the treatment of samples of human origin.
The marketing of the healthcare equipment shall mean any provision of information, ordering and inducement measures aimed at promoting the control, supply, purchase or use of equipment.
The marketing of the healthcare equipment, including advertising and other promotional activities, shall not be inappropriate and should not give an exaggerated or inaccurate picture of the device or its effectiveness or use.
The manufacturer shall be responsible for the design, manufacture, packaging and labelling of the health care device, regardless of whether the manufacturer carries out these operations himself or if any other person does it in his or her account.
The manufacturer shall provide, in the context of the healthcare device, the information necessary for the safety of its use, storage and transport. If the device is disposable, the manufacturer shall also indicate the risks that may arise if the device is reused. The information accompanying the device shall be in Finnish, Swedish or English, unless the information is provided with generally known instructions or warnings. However, the information required for the user or for the safe use of the device shall be in Finnish and Swedish. On the basis of a risk analysis, the manufacturer shall determine the information required for safe use. The instructions for use and labelling of equipment intended for self-testing and for individual use devices shall be in Finnish and Swedish.
The manufacturer shall provide the patient with a declaration of conformity of the device made available to the patient. However, there is no need to provide insurance for product category I equipment. The Agency for Social and Health Authorisation and the Agency shall, in its order, establish the content of the declaration.
The conformity of the healthcare equipment shall be demonstrated in such a way that the manufacturer classifies the device in accordance with the classification rule and selects the procedure for demonstrating compliance with the product category. The demonstration of conformity shall include a clinical evaluation with the exception of in vitro diagnostic devices.
For the purposes of compliance, the notified body shall be used if the chosen procedure so requires. The Agency for Social and Health Authorisation and Control may lay down provisions on the content and procedures of the demonstration of conformity and evaluation of the performance of in vitro diagnostic equipment.
When using the notified body, the manufacturer shall draw up documentation and correspondence enabling the conformity assessment to be carried out in the official language of the Member State of the European Union by the notified body carrying out the assessment.
The manufacturer shall monitor and evaluate, through an updated system procedure, the experience of healthcare equipment after production and information related to the clinical evaluation of the device.
The manufacturer shall keep the data required for compliance and other surveillance data for at least five years from the end of the manufacture of the healthcare equipment or for clinical studies, performance evaluation and individual The manufacture of a device intended for use. However, the storage period for implantoitav equipment shall be at least 15 years.
The manufacturer shall inform the Social and Health Authorisation and Control Agency of situations which have or may have led to the health of the patient, the user or any other person, resulting from a healthcare device:
(1) characteristics;
(2) Performance or disturbance of performance;
(3) insufficient labelling; or
4) insufficient or incorrect operating instructions.
The manufacturer shall inform the Agency of the Social and Health Authorisation and Control Agency of any technical and medical reasons relating to the characteristics and performance of the healthcare equipment as explained in paragraph 1. Systematic removal of the same type of equipment from the market.
The Agency for Social and Health Authorisation and Control may provide more detailed provisions on how the incident reports are to be made and the information to be reported.
It shall draw up, within the limits of their intended use and within the limits of their use, the equipment of health care devices bearing the CE marking in accordance with their intended use and the use made by manufacturers of equipment in the form of systems or packages of measures, A declaration of the size and the assurance of:
(1) have verified the compatibility of the equipment and its size in accordance with the instructions of the packaging or system manufacturer;
(2) that it carried out the packaging of the system or package of measures and supplied the relevant information to the users, including the relevant instructions from the manufacturers; and
(3) that all the above measures have been subject to the necessary internal control and inspection procedures.
Paragraph 1 shall not apply to in-vitro diagnostic services or active implantable medical devices.
Where the conditions laid down in paragraph 1 are not met, the system or package of measures shall be considered as a health care device and assembly manufacturer.
Where the manufacturer has intended to be sterilised by a system or a package of measures referred to in paragraph 1 or of a package of health products bearing the ce marking prior to the introduction of a sterilisation before placing on the market, the manufacturer shall: According to their choice, comply with the procedures set out in Annex II or V to the MD Directive. The application of these Annexes and the measures taken by the notified body shall be limited to the various stages of the procedure to achieve sterility until the sterile package has been opened or destroyed. The sterilator shall draw up a declaration stating that sterilisation has been carried out in accordance with the manufacturer's instructions.
The products referred to in paragraphs 1 and 4 shall contain the information referred to in point 13 of Annex I to the MD Directive, accompanied, where appropriate, by the instructions provided by manufacturers of assembled equipment and equipment. The declaration referred to in paragraphs 1 and 4 shall be kept at the disposal of the Agency for Social and Health Authorisation and Health for a period of five years from the final date of use of the equipment on the market or sterilised Or the placing on the market of the system.
The operator shall comply with the manufacturer's information and instructions on the transport, storage, installation, maintenance and other handling of the equipment.
The operator shall ensure that the device is in the condition where the manufacturer intended the device to be used for the delivery of the medical device to the end user. Where necessary, the device to be supplied to the end user other than the professional user shall be properly maintained prior to the release.
The operator shall inform the manufacturer or the authorised representative of any incident which has been identified or suspected of having a defect or defect in the device.
The producer of the manufacturer and the authorised representative, the system or package of measures, and the producer of the sterilisation service, which has its registered office in Finland, shall carry out a healthcare device during the placing on the market and the production of the service Notification to the Office for Social and Health Authorisation and Control indicating the name of the manufacturer and, where appropriate, the authorised representative, the place of business, the purpose of the appliance, the operating principle and the information to be used to identify the device. The health care device, which may pose a significant risk to health, must also provide information on the labelling and instructions for use. The importer is also subject to notification of such equipment.
Where a health equipment or human tissue or a health care device containing human blood or human blood or plasma originating in human blood or plasma derived from human blood or plasma derived from human blood or plasma is not domiciled In Finland, the importer is also obliged to report to the Agency for Social and Health Authorisation and Control. However, the obligation to notify is not in place for the use of an in vitro diagnostic device intended for the use of a professional user, which contains such substances of human origin.
The Agency for Social and Health Authorisation and Control may give more detailed provisions concerning the reporting of notifications, the information provided for in paragraph 1 and the equipment to be identified, as well as the equipment provided for in paragraph 2. Applies.
All clinical equipment studies shall be designed, performed and reported in accordance with the principles of good clinical practice.
In the case of a device intended for clinical trials, the manufacturer or his authorised representative shall draw up a declaration stating that the equipment in question complies with the essential requirements, with the exception of the aspects of the investigation, and that All necessary measures have been taken to protect the patient's health and safety.
The Agency for Social and Health Authorisation and Control may provide more detailed provisions on the procedures for carrying out the clinical examination and the information contained in the declaration.
In addition, clinical trials shall be carried out in accordance with the provisions of the Law on Medical Research, as appropriate. (488/1999) Provides.
For the initiation, management or financing of a clinical device ( The sponsor ) A notification to the Social and Health Authorisation and Control Agency of a clinical device study before the initiation of the study. The notification need not be made from a medical device bearing the ce marking if the investigation does not deviate from the intended use specified by the manufacturer. However, a clinical trial of active implantable devices must always be reported.
The clinical examination of equipment, implantable devices and the long-term invasive equipment of product category III and product category IIa and IIb may be initiated 60 days after notification, unless the Social and Health Certificate - And the Control Agency has not previously requested further clarification or has indicated that it will prohibit studies due to the risk to human health or safety. A clinical examination of other equipment may be initiated after the examination of the study has been made. In addition, the initiation of a clinical device study shall be subject to a favourable opinion from the Ethics Commission on the study.
The Agency for Social and Health Authorisation and Control may lay down provisions on the information to be communicated to it in the clinical trials and on how the data should be provided.
If the Social and Health Authorisation and Control Agency cannot accept the clinical examination of the product category IIa, II b or III referred to in Article 20 (2) or in accordance with the notification of the implantable health service, It shall ask the contractor for a further explanation of the investigation. An additional clearing request shall identify and justify all the reasons for which the investigation cannot be carried out in accordance with the research plan. The contractor may, on the basis of a request from the Agency for authorisation and supervision, amend its research plan to address the shortcomings identified. If the sponsor does not modify prior notification or amendments, no clinical examination shall be initiated, as required by the request for further clearance by the Agency.
The Agency for Social and Health Authorisation and Control may suspend or terminate the ongoing clinical examination if the investigation may present a risk to human health or safety.
Prior to the interruption of the investigation, the Agency for Social and Health Authorisation and Control shall consult the sponsor or researcher and shall provide the hearing with a period of seven days to explain or express an opinion. However, the Authorisation and Control Agency may order the investigation to be suspended immediately without consultation of the parties if the warrant is based on an imminent threat of imminent danger. If the investigation has been suspended, the authorisation and control agency shall decide separately to terminate the investigation or authorise the continuation of the investigation. The termination of an investigation shall be decided only after the parties have been consulted. (2003) In accordance with
The Agency for Social and Health Authorisation and Control shall inform the European Commission and the competent authorities of the European Economic Area of a decision prohibited by the authorisation and control agency for clinical trials Initiating or ordering the termination of an investigation for the purposes of the investigation. At the same time, the reasons for the decision must be
The Agency for Social and Health Authorisation and Control shall inform the competent authorities of the Member States concerned of a decision concerning the same study in several Member States and which:
(1) suspending research in Finland; or
(2) significant changes to the research plan or programme are required.
The Agency for Social and Health Authorisation and Control shall be informed of the suspension, completion and conclusion of a clinical device study. If an investigation has been interrupted by the investigation, the cause of the suspension shall also be reported.
Where the interruption has been due to safety reasons and the sponsor or executor of the investigation is the manufacturer or the authorised representative, this shall also be communicated to the European Commission and to the Member States of the European Economic Area.
A study report signed by a doctor or another authorised person responsible for the critical assessment of all clinical trials shall be kept by the manufacturer or his authorised representative. Data collected during the equipment investigation.
The Agency for Social and Health Authorisation and Control may provide more detailed provisions on the information to be provided to it, on the results of the investigation, on the results and on the grounds for any suspension, and on how the information should be provided.
The professional user shall ensure that:
(1) a person who uses a health care device is the training and experience required for its safe use;
(2) the equipment or accompanying instructions for safe use shall be accompanied by instructions for use;
(3) the device is used in accordance with the intended use and guidance provided by the manufacturer;
(4) the device is provided, maintained and maintained in accordance with the manufacturer's instructions and otherwise properly;
(5) the place of use is suitable for the safe use of the device;
(6) other medical devices, construction parts and structures, equipment, software or other systems and objects in immediate proximity to the device do not compromise the performance of the equipment or the patient, the user or any other A person's health; and
(7) installing, servicating and repairing only a person with the necessary expertise and expertise.
The professional user shall inform the Agency and the manufacturer or authorised representative of the health and supervisory authority and/or authorised representative of incidents that have led or may have led to the patient, the user or any other person Health hazard and which are caused by a medical device:
(1) characteristics;
(2) Performance or disturbance of performance;
(3) insufficient labelling;
(4) inadequate or incorrect use instructions; or
(5) use.
The Agency for Social and Health Authorisation and Control may lay down provisions on the manner in which such incidents are reported and the information to be reported.
The professional user shall have a responsible person responsible for ensuring that the activities of the user comply with the provisions of this law and the provisions adopted pursuant thereto.
The social and health care unit or any other professional user who has legal personality or who uses a healthcare device as a self-employed person must have a monitoring system for the use of equipment and their use. To ensure safety. The monitoring system shall be recorded:
(1) the information required for the traceability of the equipment in operation, still in operation or otherwise controlled and installed in the patient;
(2) information related to incidents arising from the use of the device; and
3) information showing that the professional user has taken care of the obligations laid down in Article 24.
The personal data collected in the monitoring system are kept secret. The information should be stored for the safety of the health device. Personal data may be disclosed to the Agency for Social and Health Authorisation and Control at its request if such information is necessary to ensure the safety of the device. The disclosure of information on marketing purposes shall be prohibited.
The Agency for Social Affairs and Health may provide more detailed provisions on the information to be recorded in the monitoring system.
The health care unit may carry out its own equipment production as provided for in this Act. The health care unit shall not carry out reprocessing or manufacture equipment containing a specific risk.
Equipment manufactured in the form of a health care unit shall not be extradited outside the health care unit of the manufacturer.
The Healthcare Unit's own equipment shall be used in accordance with the provisions of this Act and of the provisions of this Act. However, Articles 8, 9, 11 and 13 shall not apply to the own equipment of the health care unit.
Paragraph 1 shall also apply where the unit of activity changes the intended use declared by the original manufacturer or provides the product with a function as a health care device.
If a health care unit carries out its own equipment, it must be responsible for manufacturing. The health care unit shall demonstrate that its healthcare equipment is in conformity with the essential requirements. The responsible person shall approve the installation of a device manufactured in the operation unit after verifying that the device meets the essential requirements of Article 6. The health care unit shall draw up a declaration, approved by the responsible person, stating that the equipment manufactured by it complies with the essential requirements. The insurance shall be kept available to the Office for Social and Health Care and Control for a period of five years from the introduction of the device.
The Agency for Social and Health Authorisation and Control may provide more detailed provisions on the manufacture and demonstration of conformity of the health care unit.
Technical documentation shall be drawn up in the form of a healthcare device manufactured by the health care unit. The technical documentation shall allow the assessment of the risks, design, manufacture and performance of the equipment. The technical documentation shall also include:
(1) a possible sterilisation and purification method with its validation;
(2) single-use or other restriction of use;
(3) the results of design calculations and tests and checks carried out; and
(4) the results of any clinical trials.
The healthcare unit shall have the following information on centrally recorded medical equipment:
1) intended use;
(2) the year of manufacture or production;
(3) identification;
(4) raw materials;
(5) subcontractors;
(6) traceability data on a substance of biological origin;
(7) the name of the person responsible for the production; and
8) Information from the unit in which the device is used.
The manufacturer shall keep the information at least two years from the date on which the equipment was made available to the medical device, at least two years from the date of its use.
The notified body shall have the authorisation of the Office for Social and Health Authorisation and Control as notified body. The authorisation may include the conditions necessary to ensure the operation of the institution. The Office shall inform the European Commission of the notified bodies.
The notified body shall comply with the minimum requirements set out in Annex XI to the MD Directive, Annex VIII to the AIMD Directive or Annex IX to the IVD Directive. The notified body shall be deemed to comply with the above requirements if it complies with the relevant national standards adopted pursuant to the harmonised standards for which references have been published in the Official Journal of the European Union In the Official Journal. The notified body shall demonstrate by an external evaluation that it fulfils the above conditions.
The Agency for Social Affairs and Health may, where appropriate, lay down provisions on the content of the application for authorisation and the application for authorisation.
The notified body may carry out conformity assessment tasks in accordance with Annex II-VI to the MD Directive, as set out in Annexes II to V to the AIMD Directive and in Annexes III to VII to the IVD Directive.
Where a healthcare device fulfils the conditions of conformity, the notified body shall issue to the manufacturer the conformity assessment of its conformity with the EU certificate of conformity and, where appropriate, the related decision, or The inspection report. Decisions taken by the notified body in accordance with Annexes II, III, V and VI to the MD Directive, Annexes II, III and VI to the AIMD Directive and Annexes III, IV and V to the IVD Directive shall be valid for a maximum of five years. The decision may be extended for a period not exceeding five years. The notified body may require the manufacturer to provide all the information required by the selected procedure to establish and maintain a certificate of conformity.
Where an inseparable part of the product under assessment is a medicinal product or a substance derived from human blood, the notified body shall ask the competent authority of the pharmaceutical sector or the European Medicines Agency for an opinion on the quality of the substance, and Safety and the clinical disadvantage of adding a substance to the device. The opinion shall be requested from the competent authority or the European Agency for the Evaluation of Medicinal Products, including when changes are made to the excipient or its manufacturing process. The notified body shall take into account the statement of the conformity of the equipment.
The notified body may commission subcontractor submeasures in the performance of its duties provided for in paragraph 1, where the notified body has, in advance, assessed and verified that the subcontractor complies with the provisions of this Law or pursuant to it. And regulations.
The notified body shall regularly carry out appropriate inspections and assessments to ensure that the manufacturer complies with the approved quality system and shall issue an evaluation report to the manufacturer. The notified body shall take into account the results of the evaluation and inspection activities carried out during production.
The notified body shall report to the Social and Health Authorisation and Surveillance Agency information on all certificates issued, modified, completed, suspended, revoked or refused, as well as to other notified bodies Information on certificates withdrawn or withdrawn or refused, as well as on request of the licences issued. In addition, the notified body shall, on request, provide the authorisation and control agency with all relevant additional information.
If the notified body finds that the manufacturer has not complied or no longer satisfies the requirements laid down in this law, or that the certificate of conformity has not otherwise been issued, the institution shall suspend or revoke the certificate, or Be granted limited if the manufacturer fails to correct the deficiencies. Where deficiencies are identified in the certificate of conformity issued, the notified body shall submit the relevant information to the Social and Health Authorisation and Control Agency as soon as the deficiency or other reason has become Information.
The notified body shall, in the exercise of public administrative functions within the meaning of this Law, comply with the administrative law, the language of the (2003) , by law in the field of electronic business (2003) And the law on public authorities' activities (18/09/1999) Provides.
The person employed by the notified body and of this subcontractor shall be subject to the provisions relating to criminal law in the performance of the duties referred to in this Act.
The Office for Social and Health Authorisation and Control monitors the notified bodies. In order to carry out its supervisory tasks, the Office shall have the right, notwithstanding the provisions of confidentiality, to obtain the necessary information on the administration, the economy, the technical competence of the staff, the assessment of the institution's activities and the And the decisions and certificates of conformity issued by the institution.
The notified body shall inform the Agency of the Social and Health Authorisation and Control Agency of any changes in its activities which may have an impact on its operating conditions.
The Office for Social and Health Authorisation and Control may cancel the designation for a full or limited period if the notified body no longer complies with the requirements laid down in Article 32, or where the institution acts substantially in accordance with the provisions of this Act or of the provisions adopted pursuant thereto Or contrary to the provisions.
The Agency for Social and Health Authorisation and Control shall inform the European Commission and the Member States of the European Economic Area of the withdrawal of designation.
The role of the Agency for Social and Health Care and Control is to monitor and promote the safety and conformity of healthcare equipment and its use.
In order to carry out the task provided for in paragraph 1, the Office for Social and Health Authorisation and Control shall maintain a hazard record. The Agency shall evaluate the incident reports from the reporting obligations and take the necessary health and safety measures. The authorisation and control agency shall immediately inform the European Commission and the Member States of the European Economic Area of the measures taken or are to be taken to prevent the recurrence of incidents, as well as information on the incident and The events that led to it.
In market surveillance, the Agency for Social and Health Authorisation and Control shall assess in particular:
(1) whether the healthcare device complies with the requirements;
(2) whether the conformity and the placing on the market of a health care device has been carried out in accordance with applicable procedures; and
(3) is a device in the market not equipped with the CE marking under this Act, a healthcare device referred to in Article 5 (1) (1), which shall be subject to the provisions of this Act.
The Social and Health Authorisation and Control Agency shall be entitled to carry out the checks required for supervision. For the purpose of carrying out the audit, the inspector shall be entitled to access to any premises where the activities referred to in this law are carried out or are kept for information relevant to the enforcement of this law. However, the inspection shall not be carried out on the premises of domestic peace. The inspection may be carried out unannounced.
The inspection shall include all documents requested by the inspector necessary for the purpose of carrying out the inspection. In addition, the inspector shall be provided free of charge with copies of the documents necessary to carry out the inspection. The inspector also has the right to take photographs during the inspection.
A copy of the inspection shall be submitted, which shall be submitted to the party concerned within 30 days. The inspection shall be deemed to have ended when the copy of the inspection protocol has been served on the party concerned.
The inspector may lay down provisions to remedy any identified deficiencies. As a result of the provision in the audit, the subject of the inspection shall immediately take the necessary measures.
The Social and Health Authorisation and Control Agency shall keep the inspection protocol for 10 years from the date of the inspection.
The Social and Health Authorisation and Control Agency shall have the right to study and test health equipment and other products if it is necessary for the enforcement of this law. The samples taken to be examined and tested shall be replaced by the fair price, where the holder so requires. However, a sample of samples to be tested and tested shall not be replaced if the investigation finds that the device is contrary to this law.
Where a healthcare device does not meet the requirements laid down in this Act, the Agency for Social and Health Care and Control may oblige the manufacturer or the authorised representative to pay for the procurement, research and testing Necessary costs. However, the costs to be reimbursed must be proportionate to the measures taken under the supervision and the quality of the infringement.
Where appropriate, the police shall provide administrative assistance to the Social and Health Authorisation and Control Agency for the performance of the duties provided for in Articles 39 and 41.
The Social and Health Authorisation and Control Agency shall have the right to use external experts to assess the characteristics, safety and conformity of the healthcare equipment. External experts may participate in inspections under this law, as well as examine and test medical equipment.
An external expert shall have the necessary expertise and competence. An external expert shall be subject to the provisions of the administrative code relating to the aesthetic of the official, as well as criminal liability in the performance of his duties as referred to in this Act.
Where a manufacturer, an authorised representative, a professional user or an operator has failed to fulfil its obligations under this law, the Agency for Social and Health Authorisation and Control may order the obligation to be completed within the time limit.
Where the health care equipment placed on the market or placed on the market has not been prepared for conformity assessment documentation or the documentation provided by the manufacturer is incomplete or incorrect, The authorisation and control agency may order the manufacturer to draw up missing documents or correct inadequacy or inaccuracies in the documents within the time limit. If, in spite of the order of the authorisation and control agency, the deficiencies or inaccuracies in the documents are not corrected, the authorisation and control agency may prohibit the manufacture, sale and other distribution of the device.
Paragraph 1 shall also apply where a product which is not a medical device has been erroneously applied in accordance with the provisions of this Act, including those provided for by the ce marking.
Where a health care device is harmful to health or inappropriate for use, or where the ce marking has been wrongly affixed to the device, or the ce marking is missing in contravention of this law, the Social and Health Authorisation-and The Supervisory Board may:
(1) order the manufacturer or his authorised representative to take the necessary measures to bring the device into conformity with the provisions of this Act and the provisions adopted pursuant thereto;
(2) prohibit the manufacture, sale, export or other free distribution of the equipment; and
(3) impose conditions on the availability or use of the equipment.
Before a final decision is taken, the Social and Health Authorisation and Control Agency may adopt a provisional decision, when there is a specific reason. The provisional decision shall remain in force until the final decision is taken pursuant to paragraph 1.
Where the ce marking on a healthcare device is affixed to a product which is not a health care device, the Social and Health Authorisation and Control Agency may oblige the manufacturer or his authorised representative to take action on the product Recall or prohibit the placing on the market and the placing in service of the product.
In accordance with Articles 45 or 46, the Agency for Health and Welfare may, at the same time, instruct the manufacturer or his authorised representative to take measures relating to the equipment in place which: , the hazards associated with the device may be prevented.
For the purposes of paragraph 1, the manufacturer or the authorised representative may be obliged to:
(1) repair the medical device in question in such a way that the health care provided in its characteristics or in terms of a defect or deficiency in its performance or of a false, misleading or incomplete information resulting from it; Risk elimination ( Repair ); or
(2) remove from the market the health care equipment which, for technical or medical reasons, may pose a health risk to the patient, the user or any other person ( Market withdrawals ).
Where the manufacturer or the authorised representative is not intended and the device is dangerous to health, the Agency for Social and Health Authorisation and Control may also oblige the operator to act in accordance with paragraph 2 (2).
Where a health, safety or health care device or a legal team may compromise health protection, safety or health, the Social and Health Authorisation and Control Agency may prohibit the sale, release and use of the equipment, or impose conditions or Restrictions on donation or use.
The Social and Health Authorisation and Control Agency may oblige the manufacturer or his authorised representative to report on the prohibition or order, the risk related to the health service or its use, and the risk Within the time limit set by the authorisation and control agency and in a manner prescribed.
The Agency for Social and Health Care and Control shall inform the European Commission of the decision taken pursuant to Article 46 and the grounds for it if the decision concerns a health care device bearing a ce marking, or The absence of a device manufactured for an individual use or the absence of the ce marking required by this law on the apparatus and the device, if used in accordance with its intended purpose, may endanger patients, users, or The health or safety of other persons.
If, pursuant to Article 46 or Article 47, the Social and Health Authorisation and Control Agency carries out a decision pursuant to Article 46 or Article 48, the Agency shall immediately inform the European Commission of the decision and the reasons therefor. And Member States of the European Economic Area.
If the marketing of a health care device has been carried out in contravention of Article 11, the Agency for Social Affairs and Health may refuse to renew or renew marketing. The authorisation and control agency may also order the recipient of the prohibition to correct the incorrect or incomplete information it has given in marketing, if it is deemed necessary for reasons of compromise.
An order or a decision adopted by the Office for Social and Health Authorisation and Control pursuant to this Chapter may be made more effective by a periodic penalty payment or at risk of commissioning, as in the case of the (1113/1990) Provides.
The threat of fraud is set by imposing a primary obligation on the risk of failure to do so, to the detriment of the defaulter.
Where a provision or decision adopted pursuant to this Chapter has not been complied with within the prescribed period, the Agency for Social and Health Authorisation and Control may fulfil the obligation imposed at the expense of which the obligation has been imposed. If the authorisation and control agency meets the obligation itself, the penalty payment imposed by the mandatory decision or order shall not be passed on.
General control and supervision of activities under this law is a matter for the Agency for Social and Health Authorisation and Control.
In addition to the tasks of the Agency for Social and Health Authorisation and the Agency, the Agency shall carry out the tasks assigned to the competent authority in the acts of the European Union relating to healthcare equipment.
If it is not clear whether the device or article is a medical device covered by this law, or if the notified body and the manufacturer disagree as to where a device belongs to the product category of the healthcare equipment, the Social and Health Authorisation and The control agency shall decide on the classification of the product.
The Social and Health Authorisation and Control Agency shall provide the following information in the European healthcare equipment database:
(1) information in accordance with Article 18 (1), with the exception of equipment manufactured for individual use, as well as information on health equipment produced by the health care unit;
(2) information on the issue, amendment, supplementing, suspension, withdrawal or refusal of certificates issued by the notified body;
(3) information received on the basis of an incident monitoring procedure; and
(4) information obtained on the basis of clinical trials reports.
Data collected in the database may only be used for regulatory control purposes.
The Agency for Social and Health Authorisation and the Agency may grant an application for a temporary derogation for the placing on the market and the use of a single health device, even if the conformity assessment of the equipment is not: Implemented in accordance with this law or by the provisions adopted pursuant to it and in accordance with the provisions thereof, if:
(1) the device is necessary to alleviate or treat a serious illness or injury to the patient;
(2) no other equivalent device is available; and
(3) the applicant shows that the essential requirements for the device are met.
The Agency for Social and Health Authorisation and Control may attach conditions to the safety of the device and its use.
The Social and Health Authorisation and Control Agency shall have the right to receive, free of charge and without prejudice to the provisions of confidentiality, the information necessary for the purpose of supervision by the authorities of the State and of the municipality and of the natural or legal persons to whom this law or its Shall be subject to the provisions and provisions adopted.
The information and confidentiality of the information received by the authorities and the notified body in carrying out the tasks conferred by this Act and the provisions adopted pursuant thereto shall be governed by the law of the public authorities, or Other law provided for. In addition, the public are drawn up or received in the context of the implementation of this law:
1) Data on the equipment register maintained by the Agency for Social and Health Authorisation and Control;
(2) the information provided by the manufacturer or operator to users on the events and the prevention of incidents; and
(3) information relating to certificates issued, amended, supplemented and suspended by the notified body.
Without prejudice to the obligation of professional secrecy laid down in Articles 56 (2) and 56 (2) of the Act on Public Access to the Activities of the Authority, the Office may extradite compliance with this law and the provisions adopted pursuant to it. The information received by the private or community economic position, business or professional secret or the state of health or personal circumstances of a private person:
(1) to the State authority for the purpose of carrying out its duties under this law;
(2) prosecuting, police and customs officers to investigate the offence;
(3) for the exchange of information between the Authority and the notified body; and
(4) the competent foreign authority and the international institution for the implementation of an obligation under an international agreement which is binding on the European Union Directive or Finland.
The decision referred to in Articles 21, 37, 44 to 49 and 51 of this Act shall be subject to appeal by the administrative court, in accordance with the administrative law (18/06/1996) Provides.
With regard to the decision of the Agency for Social and Health Protection and Control, the order to be issued at the time of its inspection and the decision of the notified body shall be required to be corrected by the Social and Health Authorisation and Control Agency, as in the Administrative Act. Provides.
The decision on the request for adjustment shall be subject to appeal by the administrative court as provided for in the administrative law.
In the case referred to in paragraph 1, the administrative right shall be subject to appeal as laid down by the Law on Administrative Law. An appeal against any other decision of the administrative court may be lodged only if the Supreme Administrative Court grants an appeal.
The decisions and provisions of the Office for Social and Health Authorisation and Control shall be followed in spite of the appeal.
If, pursuant to Article 21, the Social and Health Authorisation and Control Agency has suspended a clinical examination or a provisional decision pursuant to Article 46, the decision shall not be appealed against.
L to 25/2015 Article 58 will enter into force on 1 January 2016. The previous wording reads:
Any decision taken by the Social and Health Authorisation and Control Agency under this Act shall be subject to appeal to the administrative court, as in the case of administrative law (18/06/1996) Provides.
In the context of an inspection carried out by the Office for Social and Health Authorisation and Control, the decision to be issued by a notified body under this law shall not be appealed against. The order or decision shall be subject to an appeal from the authorisation and control agency within 30 days of the date of receipt of the decision or the end of the inspection. The order and the decision shall be accompanied by instructions in order to bring the request for review to the authorisation and control agency. Despite the need for a correction, measures must be taken in accordance with the provisions. The decision to make an appeal against the decision by the Office for Social and Health Authorisation and Control shall be subject to appeal as provided for in paragraph 1.
The decision or provision adopted by the Social and Health Authorisation and Control Agency under this Act shall, in spite of the appeal, be complied with, unless otherwise specified by the appeal authority.
If, pursuant to Article 21, the Social and Health Authorisation and Control Agency has suspended a clinical examination or a provisional decision pursuant to Article 46, the decision shall not be appealed against.
Every deliberate or gross negligence
(1) put the health service on the market or introduce it in breach of Article 8;
(2) fails to comply with the obligation laid down in Article 12 for the design, packaging or marking of a healthcare device,
(3) fails to comply with the obligation to monitor the obligation laid down in Article 14;
(4) fails to comply with the obligation laid down in Article 15 to notify the Agency for Health and Welfare in the event of an incident;
(5) fails to comply with the obligation laid down in Articles 20 and 23 to notify a clinical trial;
(6) fails to comply with the obligation laid down in Article 25 to notify dangerous situations or
(7) fails to comply with the prohibition or order referred to in Articles 44 to 49,
Shall be condemned unless a heavier penalty has been imposed elsewhere, Violation of the law on medical equipment and supplies Fine.
Any violation of a penalty or order made by a periodic penalty payment pursuant to Articles 46 to 49 or 51 may be waived for the same offence.
If there is reason to believe that this law has been breached, the Social and Health Authorisation and Control Agency shall report to the investigating authority. The notification may not be made if the suspected criminal offence is minor and if it appears that the act has been taken into account in the light of the circumstances of negligence or thoughtlessness, and the public interest does not require notification.
This Act shall enter into force on 1 July 2010. However, Articles 26 to 31 shall apply only from 1 January 2011 and Article 54 shall apply from 5 September 2012.
This law repeals the law on medical devices and articles (1505/1994) .
If any other law refers to the Law on Medical Devices and Supplies, the reference shall be understood to mean this law.
Before the entry into force of this Act, measures may be taken to implement the law.
Where a health care device is affixed by a ce marking other than that affixed under this Act and, during a transitional period, the manufacturer is free to choose the applicable system, the CE marking shall indicate that the health service complies with: Only the provisions and regulations applied by the manufacturer. In that case, the reference numbers of the acts of the European Union, as published in the Official Journal of the European Union, shall be entered in accordance with these instruments in the documents, notices or instructions accompanying the equipment.
THEY 46/2010 , StVM 9/2010, EV 70/2010, Council Directive 90 /385/EEC (31990L0385); OJ L 189, 20.7.1990, p. 17-36, Council Directive 93 /42/EC (31993L0042); OJ L 169, 12.7.1993, p. 1-43, European Parliament and Council Directive 98 /79/EC (31998L0079); OJ L 331, 7.12.1998, p. 1-37, European Parliament and Council Directive 2007 /47/EC (32010L247); OJ L 247, 21.9.2007, p. 21 TO 55This Act shall enter into force on 1 April 2015.
THEY 164/2014 , StVM 27/2014, EV 195/2014
This Act shall enter into force on 1 January 2016.
In the case of appeals before the entry into force of this Act, the provisions in force at the time of entry into force of this Act shall apply.
THEY 230/2014 , LaVM 26/2014, EV 319/2014
