Published: 2010-12-10
Key Benefits:
Passed 13.12.2004 Annex 354
RT I 2004, 85, 581
Entry into force 19.12.2004
| 10.12.2009 | RT I 2009, 63, 415 | 01.01.2010 |
| 06.12.2010 | RT I, 07.12.2010, 7 | 10.12.2010, word “quality system” is replaced by the word “quality management system” throughout the text |
The Regulation is established under subsection 23 (2) of the “Medical Devices Act”.
The Regulation establishes the procedure of conformity assessment of a medical device.
(1) To using of tissue of animal origin in the production of a medical device, Directive 2003/32/EC of the European Commission dated April 23rd, 2003 is applied in addition to the present Regulation, where detailed requirements to medical devices manufactured by using tissues of animal origin provided in Directive No. 93/42/EEC of the Council of the European Community are described (Official Journal of the European Union L 105, 26.04.2003, pages 18–23).
(2) The Administrative Procedures Act is applied to the administrative procedure provided in the present Regulation, considering the differences in the Medical Devices Act and the present regulation.
The procedures of conformity assessment of a medical device are the following:
1) full quality assurance;
2) quality assurance of the production process;
3) quality assurance of the final inspection of a medical device;
4) verification;
5) type examination;
6) conformity declaration;
7) drafting of a statement.
(1) Before placing of a medical device on the market it needs to pass conformity assessment
(2) The manufacturer selects the applicable conformity assessment procedure, relying on the type of the assessed medical device. The manufacturer may also select a conformity assessment procedure designed for a medical device of higher class.
(3) Conformity assessment of a medical device is completed by drafting of a conformity declaration according to the Medical Devices Act and placement of CE marking on a complying medical device.
(4) A CE marking is not placed on a custom-made medical device, clinically examined medical device and on a medical device for assessment of performance; for such devices the manufacturer drafts a statement as a result of the conformity assessment.
(5) An authorised representative of the manufacturer has a right to carry out the following procedures of conformity assessment:
1) type examination;
2) verification;
3) conformity declaration;
4) drafting of a statement.
(1) If the conformity assessment of a medical device requires the inclusion of a notified body, the manufacturer or an authorised representative of the latter selects a suitable notified body for the conformity assessment of the relevant medical device.
(2) Inclusion of a notified body in the conformity assessment of a medical device is obligatory upon placing on the market a medical device with measurement function belonging to class I, a medical device belonging to class IIa, IIb and III, and a dangerous in vitro diagnostic medical device.
(3) Upon the conformity assessment of a medical device the manufacturer, notified body or both must consider the results of all assessment and certification procedures carried out upon the manufacturing of the medical device, whereas such assessment and certification procedures shall be carried out according to the requirements of the Medical Devices Act and the legislation enacted thereunder.
(4) When reasonable, a notified body may request additional information about the device necessary for the conformity assessment.
(5) A decision made in regard to the full quality assurance, type examination, quality assurance of the manufacturing process and quality assurance of the final inspection of a medical device is valid for five years. The validity of a decision may be extended for five years, if such a possibility is provided in the agreement between the notified body and the manufacturer.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(6) The documentation associated with conformity assessment is submitted in Estonian or the language of another member state of the European Economic Area accepted by the notified body. The documents can also be in both languages.
Upon the conformity assessment of a medical device of class I the manufacturer declares the conformity of the medical device and drafts a conformity declaration in regard thereto before placing the medical device on the market.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(1) Upon the conformity assessment of a medical device of class II a the manufacturer drafts a conformity declaration after the completion of conformity declaration procedures with one of the following conformity assessment procedures:
1) conformity certification;
2) quality assurance of the manufacturing process;
3) quality assurance of the final inspection of the medical device. [RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(2) Upon the conformity assessment of a medical device the manufacturer may complete only the full quality assurance procedure instead of the procedures stated in section 1.
(3) Upon the conformity assessment of a medical device of class II b the manufacturer drafts a conformity declaration after the completion of one of the following conformity assessment procedures:
1) full quality assurance to which § 25 is not applied;
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
2) type examination with conformity certification, quality assurance of the manufacturing process or quality assurance of the final inspection of the medical device.
Upon the conformity assessment of a medical device of class III the manufacturer drafts a conformity declaration after the completion of one of the following conformity assessment procedures:
1) full quality assurance;
2) type examination with conformity certification or quality assurance of the manufacturing process.
(1) Upon the conformity assessment of an in vitro medical device not belonging among the medical devices of list A and B and self-testing medical devices the manufacturer declares the conformity of the device and drafts a conformity declaration in regard thereto.
(2) Upon the conformity assessment of an in vitro diagnostic medical device belonging to list A the manufacturer drafts a conformity declaration after the completion of one of the following conformity assessment procedures:
1) full quality assurance;
2) type examination with quality assurance of the manufacturing process.
(3) Upon the conformity assessment of an in vitro diagnostic medical device belonging to list B the manufacturer drafts a conformity declaration after the completion of one of the following conformity assessment procedures:
1) full quality assurance;
2) type examination with conformity certification or quality assurance of the manufacturing process.
(4) Upon the conformity assessment of a self-testing medical device the manufacturer drafts a conformity declaration after the completion of a procedure provided in section 2 or 3 or the assessment of the design of a self-testing medical device.
Upon the conformity assessment of an active implantable medical device the manufacturer drafts a conformity declaration after the completion of one of the following conformity assessment procedures:
1) full quality assurance;
2) type examination with conformity certification or quality assurance of the manufacturing process.
(1) Conformity declaration is a procedure of conformity assessment by which the manufacturer or an authorised representative thereof ensures and certifies that the medical device complies with the requirements of the Medical Devices Act and the legislation established thereunder.
(2) As a result of the conformity declaration, the manufacturer or an authorised representative thereof drafts a conformity declaration for a medical device complying with the requirements.
(1) For conformity declaration, the manufacturer or an authorised representative thereof shall draft technical documentation for the medical device.
(2) The technical documentation shall make it possible to assess the conformity of the medical device to the requirements of the Medical Devices Act and the legislation established thereunder. The technical documentation shall include the following information:
1) general description of the device, including the descriptions of all planned varieties of the device, and the intended purpose of the product;
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
2) layout drawings and manufacturing methods, layout and drawings of the parts, accessories, power circuits, etc. of the medical device and descriptions and explanations necessary to understand the principles of operation of those and the relevant device;
3) results of risk analysis and, if necessary, references to harmonized standards partly or fully followed in the manufacturing of the device; if there no harmonized standards have been followed, the solutions applied for following of the requirements established in the Medical Devices Act and legislation established thereunder;
4) design calculations and results of inspections by the manufacturer;
5) in the event of a device placed on the market as sterile, the description of sterilization methods and validation report;
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
6) if it is necessary to connect the medical device with another medical device meeting the characteristics described by the manufacturer in order to use it for the intended purpose, it must be certified that the device meets the requirements to medical devices also after the connection;
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
61) measures for liquidation or minimization of dangers associated with the device; [RT I, 07.12.2010, 7 – entered into force 10.12.2010]
7) pre-clinical and clinical assessment;
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
8) labelling and user manual of a medical device.
(3) In addition to the information provided in section 2, the technical documentation of an in vitro diagnostic medical device shall include the following information:
1) documentation of the quality management system;
2) information about the design of the medical device, including the description of the main materials, characteristics and operational limitations;
3) in the event of a medical device containing human tissues or derivatives obtained from those, information regarding the origin of such materials and collection terms thereof;
4) in the event of a medical device of special microbiological condition or state of cleanliness, a description of the procedures used;
5) information characterizing the operational capacity designed by the manufacturer and results of benchmarking measurements confirming those, if available, from performance assessment inspection results or from relevant biographic references;
6) information regarding the benchmarking methods and substances, known benchmarking values, precision and measurement units used;
7) results of stability inspections of the device.
In the stage after manufacturing, the manufacturer shall create and continually update a systematic inspection procedure for processing information about the medical device. Also, the manufacturer shall apply necessary measures for adjusting the production process based on the nature of the collected information and dangers associated with the device. In the stage after manufacturing, the manufacturer shall continually update the clinical assessment based on the clinical information collected.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(1) Upon the conformity assessment of a medical device placed on the market as sterile and with a measurement function belonging to class I the manufacturer drafts a conformity declaration after the completion of one of the following conformity assessment procedures:
1) conformity certification;
2) quality assurance of the manufacturing process;
3) quality assurance of the final inspection of the medical device;
4) full quality assurance.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(2) Application of the procedures provided in section 1 and inclusion of notified bodies is limited to the parts of the production process:
1) ensuring the sterility of medical devices placed on the market and preservation thereof, or
2) ensuring the conformity of a manufactured device to a measurement function to metrological requirements.
(1) With the conformity declaration, a manufacturer of a medical device belonging to class II a confirms that the medical device has been manufactured according to the technical documentation described in § 12 and the requirements of the Medical Devices Act and the legislation established thereunder.
(2) If a manufacturer of a medical device of class II a has carried out a procedure of conformity certification, quality assurance of the manufacturing process or quality assurance of the final inspection of a medical device, he shall draft one conformity declaration based thereon. By the conformity declaration the manufacturer represents and warrants that the design of medical device of class II a corresponds to the requirements of the Medical Devices Act and the legislation established thereunder.
The manufacturer shall apply the necessary measures to ensure the conformity to quality management principles appropriate for the relevant device in the manufacturing process. The quality management system includes:
1) the organisational structure and obligations;
2) manufacturing process and systematic inspection procedure of the medical device;
3) measures by which the performance of the quality management system is checked.
(1) A manufacturer of self-testing medical devices submits an application for assessment of the design of a device to a notified body.
(2) The application for assessment of the design shall be drafted so that the notified body can easily understand the design of the device and assess the conformity thereof to the design requirements under the Medical Devices Act and legislation established thereunder. The application shall include the following information:
1) reports of test results and, if necessary, information regarding the results of research carried out with regular users;
2) description of handling of the device and suitability of the device for self-testing;
3) information contained in the labelling and user manual.
(3) The notified body may reasonably request additional test results from the manufacturer, or evidence making it possible to assess the conformity of the device to the design requirements under the Medical Devices Act and legislation established thereunder.
(4) The notified body assesses the submitted application and issues an assessment certificate of the design of the self-testing medical device conforming to the requirements.
A design assessment certificate issued by a notified body includes information about the identification information of the design, results of the assessment of the design, validity of the certificate of the approved self-testing medical device, and, if necessary, ways of using the device according to the intended purpose.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
The manufacturer shall inform the notified body having issued the design assessment certificate of every important approved change in the design that can influence the terms of use of the device or the conformity of the design to requirements. The notified body assesses the intended changes and issues an annex to the design assessment certificate in the event of an approval.
(1) Full quality assurance ensures the quality of the design, manufacturing process and final inspection of the medical device approved by the notified body, and the notified body shall perform surveillance and inspect the application thereof.
(2) By full quality assurance provided in section 1, the manufacturer confirms that the relevant medical devices comply with the requirements of the Medical Devices Act and the legislation established thereunder.
(3) According to the Medical Devices Act the manufacturer shall place a CE marking on the device and draft a conformity declaration including one or several medical devices manufactured, which are clearly identified by a product name, product code or another explicit reference. The manufacturer shall preserve the conformity declaration.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(4) In addition to the provisions of section 3, the CE marking of an active implantable medical device shall include the identification number of the notified body having performed the conformity assessment.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(1) The manufacturer shall submit an application to the notified body for the assessment of the quality management system, including the following information:
1) name and address of the manufacturer and of every place of operation included in the quality management system;
2) relevant information of the medical device or type thereof included in the quality management system;
3) a statement by which the manufacturer guarantees that no application has been submitted to another notified body in regard to the quality management system concerning the same medical device;
4) documentation of the quality management system;
5) commitment of the manufacturer to fulfil the duties associated with the approved quality management system;
6) commitment of the manufacturer to maintain the conformity of the approved quality management system to requirements and the efficiency of the system;
7) statement of the manufacturer to systematically collect information in regard to the medical device and update the information obtained after the manufacturing;
8) statement of the manufacturer to employ measures provided in clause 7 to ensure the necessary improvements in the quality management system and ensure reporting of a risk event upon the occurrence thereof.
(2) The application for assessment of the quality management system of an active implantable medical device does not have to include the information provided in clauses 1 and 3 of section 1.
(1) Application of a quality management system shall ensure the conformity of a medical device to the requirements of the Medical Devices Act and the legislation established thereunder in every stage of production – from planning to the final inspection. All the components, requirements and conditions of a quality management system shall be systematically and regularly documented as a quality policy, programmes, procedures, plans, manuals and records. The documents shall include the following information:
1) quality goals of the manufacturer;
2) organisation of the company’s operations, including the organisational structure, responsibility of the management and the extent thereof in regard to the quality of manufacturing and planning;
3) surveillance methods of efficient performance of the quality management system, first of all the capability to achieve the desired quality of planning and the quality of the medical device with the help of the system, including the detection of a medical device not complying with the requirements and in events when the design, manufacturing or final inspection and testing are performed by a third person.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(2) First of all the following information must be submitted for the surveillance and control methods of the design of a medical device:
1) general description of the device, including all planned varieties of the device, and the intended purpose of the product;
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
2) specifications of the design, including the list of applicable standards and results of risk analysis, as well as a description of solutions necessary for the fulfilment of general requirements associated with the medical device, if the standards are not fully applied;
3) control and assessment procedures of the design and manufacturing process of the medical device, and systematic measures applied during the design;
4) if it is necessary to connect the medical device with another medical device meeting the characteristics described by the manufacturer in order to use it for the intended purpose, it must be certified that the device meets the requirements to medical devices also after the connection;
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
5) a notice of the content of a blood product or medicinal product in the medical device, as well as information about research carried out for the blood product or a medicinal product during which the safety, quality and efficiency of the blood product or medicinal product were assessed, considering the intended purpose of the device;
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
51) a statement according to Directive No. 2003/32/EC in regard to the device having been or having not been manufactured, using animal tissues;
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
52) measures for liquidation or minimization of dangers associated with the device;
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
6) pre-clinical and clinical assessment;
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
7) labelling design and user manual, if necessary.
(3) First of all the following information must be submitted about the methods of inspection and quality assurance in manufacturing stage:
1) procedures associated with the acquisition and sterilisation and documents associated with the latter;
2) procedures used for identification of the device based on drawings, specifications and other important documentation in every stage of manufacturing, updating thereof and other important information;
3) tests and series of tests carried out before, during and after the manufacturing, the frequency thereof and the test equipment used;
4) in addition to the provisions of clause 3, it must be possible to detect the calibration of the test equipment.
(4) The documentation of the quality management system of an in vitro diagnostic medical device does not have to include the information provided in clauses 2, 4, 5, 51, 52, 6 and 7 of section 2. In addition to clauses 3 and 4 of section 3, the manufacturer of an in vitro diagnostic medical device shall organise the tests and inspections required by the notified body at the level of modern equipment. The inspections and tests shall include the whole production process, including:
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
1) a description of the properties of the raw material used;
2) descriptions of a single medical device or every lot of medical devices manufactured;
3) information provided in clauses 2 to 8 of section 2 and 2 to 7 of section 3 of § 12;
4) information provided in section 2 of § 17 for self-testing medical devices.
(5) Upon the testing of an in vitro diagnostic medical device belonging to list A the manufacturer shall rely on the most recent available information. First of all it concerns the biological complexity and variability of the samples tested with the device.
(6) The documentation of the quality management system of an active implantable medical device does not have to include the information provided in clauses 2, 4, 5, 51, 52, 6 and 7 of section 1.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(1) To determine the conformity to the requirements established in paragraph 22, the notified body assesses the quality management system of a manufacturer upon a relevant application by the manufacturer. It is presumed that quality management systems associated with relevant harmonised standards meet the requirements.
(2) At least one expert with previous experience in assessment of the relevant technology shall participate in the inspection. Inspection of the production process shall include the assessment of the design documents of the relevant device according to the representative sample, and inspection of the place of manufacturing and in justified cases the place of operation of the suppliers, subcontractors or both of the manufacturer. The manufacturer shall be informed of the results of the inspection.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(3) Inspection of an active implantable medical device is only connected with the production location of the manufacturer.
(1) The manufacturer informs the notified body having approved the quality management system of every planned change in the quality management system.
(2) The notified body assesses the planned changes and determines if the quality management system meets the requirements established in § 22 after the implementation of the changes.
(3) The notified body submits its decision to the manufacturer, including the conclusions of the inspection and an assessment with reasons.
(1) The manufacturer shall apply for an assessment of the documentation of the design of a medical device according to which the manufacturer is planning to manufacture the medical device. The design of a medical device belonging to class II a or II b is not to be assessed.
(2) An application for assessment of a design of a medical device shall include the following:
1) the design;
2) a description of the manufacturing;
3) a description of the operation;
4) documents provided in section 2 of § 22 enabling the assessment of the conformity of the medical device to the requirements of the Medical Devices Act and the legislation established thereunder;
5) [Repealed - RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(3) In the event of assessment of a design of an in vitro diagnostic medical device the manufacturer submits an assessment application of the design to the notified body, including the following information in addition to the information provided in clauses 1 to 3 of section 2:
1) provisions of section 1 of § 21;
2) provisions of section 2 of § 22.
(4) In the event of an assessment of a design of active implantable medical device the manufacturer submits an application of assessment of the design, including the following information in addition to the information provided in clauses 1 to 3 of section 2:
1) a description of the properties of the device enabling the assessment of the conformity of the active implantable medical device to the requirements of the Medical Devices Act and the legislation established thereunder;
2) design specifications, including the harmonized standards applied;
3) references to harmonized standards that have been partly or fully observed during the manufacturing of the device; if harmonized standards have not been fully observed, the solutions applied for following the requirements of the Medical Devices Act and the legislation established thereunder;
4) results of tests performed by the manufacturer or under the manufacturer’s responsibility to certify the suitability of the solutions provided in clause 3;
5) if the medical device includes a medicinal product as a component under the Medicinal Products Act, a statement based on test results that the medical device facilitates the improved metabolism of the medicinal product in human organism;
6) clinical information;
7) layout of the user manual.
(5) The notified body assesses the submitted application and issues an assessment certificate of the design of the medical device complying with the requirements. The design assessment certificate includes the identification information of the approved design of the medical device, assessment results of the design, information about the validity of the certificate and, if necessary, of methods of use of the device for the intended purpose.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(6) Before providing the final assessment of the design, the notified body consults the following parties in order to verify the quality, safety and efficiency of the substance included in the device:
1) one competent authority appointed by the member states or the European Medicines Agency (hereinafter EMA), if the medical device contains a medicinal product as an inseparable component under the Medicinal Products Act;
2) the EMA, if the medical device contains a blood product as an inseparable component under the Medicinal Products Act.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(7) A competent institution of EMA shall draft an opinion within 210 days from receiving the valid documents. The scientific opinion of a competent institution or EMA shall be enclosed with the documents regarding the device. The notified body considers the above described opinion and in regard to devices provided in clause 2 of section 6 does not issue an assessment certificate of the design, if it contradicts the opinion of EMA. The notified body submits its final decision to a competent authority having provided the opinion.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(8) In the event of devices manufactured of tissues of animal origin provided in Directive 2003/32/EC of the Committee, the notified body follows the procedures established in the Directive.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(1) The manufacturer shall inform the notified body having issued the design assessment certificate of every change in the design of the device that can influence the conditions of use of the device or the conformity of the device to the general requirements to the medical device.
(2) The notified body issues an annex to the design assessment certificate for approval of the changes implemented.
(3) A manufacturer of in vitro diagnostic medical device shall inform the notified body immediately of all known changes in infection markers or pathogens, especially changes based on biological variability and complexity. The manufacturer shall inform the notified body of all known probable influences of the changes in regard to the operation of invitro diagnostic medical device.
(1) The purpose of the surveillance of a quality management system is to ensure that the manufacturer fulfils obligations under the approved quality management system with due diligence. The notified body performs surveillance of the application of the quality management system.
(2) The notified body shall organise periodical inspections to ensure the maintenance and application of the quality management system by the manufacturer. If necessary, the notified body may perform tests or have tests performed in order to check the efficient performance of the quality management system. The notified body shall submit an inspection report to the manufacturer of the medical device and in the event of tests a report in regard to the results thereof.
(3) The manufacturer shall allow the notified body to inspect the performance of the quality management system and submit necessary information for that, first of all the following:
1) documents associated with the quality management system;
2) information associated with the design, including the results of tests, calculations, research, pre-clinical and clinical assessment, plan of clinical marketing follow-up inspection and the results of clinical marketing follow-up inspection, if available;
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
3) information of manufacturing stages of medical devices under the quality management system, including control, tests, calibration and qualification of the personnel.
(4) The notified body may inspect the manufacturer of medical devices without a prior notice. If necessary, upon such an inspection, the notified body may carry out or ask the manufacturer to carry out tests by which the conformity of the quality management system may be checked. After the inspection the notified body shall submit an inspection report and results of possible tests to the manufacturer.
(1) In the event of devices of class II a, the notified body assesses the conformity of the technical documentation to the provisions of the Medical Devices Act for at least one sample selection per every subcategory of devices.
(2) In the event of devices of class II b, the notified body assesses the conformity of the technical documentation to the provisions of the Medical Devices Act for at least one sample selection per every general group of devices.
(3) Upon choosing the sample selection, the notified body considers the innovation of the technology, similarities of design, technology, manufacturing and sterilisation methods, intended purpose and the previous results of relevant assessments according to the Medical Devices Act (e.g. in regard to physical, chemical or biological properties). The notified body documents the principles of choosing the selection and keeps it accessible for the competent authority.
(4) The notified body assesses the additional selections as a part of the surveillance of the application of the quality management system and keeping it up to date.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
10.03.2011 11:23
Correction of a mistake – title of § 27'2 added according to the provisions of clause 27 of § 1 of Regulation No. 165 by the Government of the Republic dated December 6th, 2010“. Basis: Section 4 of § 10 of the Riigi Teataja Act.
The manufacturer or an authorised representative thereof shall keep the following documents available for the Health Board at least for five years and in the event of implantable medical devices at least for 15 years from the manufacturing of the last device:
1) conformity declaration;
2) documents, data and records regarding the quality management system and amendments thereto, first of all in regard to procedures;
3) documents regarding the assessment of conformity of the product to the requirements to medical devices;
4) a decision of the notified body and reports regarding the quality management system of the manufacturer and checking thereof, including inspections and scientific opinions provided in sections 6 to 8 of § 25.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
The manufacturer informs the notified body always before placing a lot of medical devices containing blood products as inseparable parts thereof on the market, and submits certificates proving the quality and safety of the blood product used in the device issued by a national laboratory or a laboratory assigned by a member state for that purpose in accordance with section 2 of article 114 of Directive 2001/83/EC.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(1) For assessment of conformity of an in vitro diagnostic medical device belonging to list A, the manufacturer shall submit relevant reports regarding the manufactured medical device or a lot thereof to the notified body after the results of the inspections and tests are available.
(2) The manufacturer shall enable access for the notified body to samples of the manufactured medical device or a lot thereof according to previously agreed conditions and methods.
(1) If the notified body has not informed the manufacturer of a negative decision within the agreed term (but not later than 30 days after the reception of samples of the medical device), the manufacturer may place the in vitro diagnostic medical device belonging to list A on the market.
(2) The notified body shall inform the manufacturer of changing the terms of validity of the design assessment certificate issued during the term provided in section 1.
(1) Quality assurance of the manufacturing process is a procedure by which the manufacturer confirms the application of the quality management system approved by the notified body to the manufacturing of the relevant medical device. The notified body performs surveillance of the quality assurance of the manufacturing process.
(2) By quality assurance of the production process provided in section 1, the manufacturer confirms that the relevant medical devices comply with the requirements of the Medical Devices Act and the legislation established thereunder.
(3) According to the Medical Devices Act the manufacturer shall place a CE marking on the device and draft a conformity declaration including one or several medical devices manufactured, which are clearly identified by a product name, product code or another explicit reference. The manufacturer shall preserve the conformity declaration.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(4) In addition to the provisions of section 3, the CE marking of an active implantable medical device shall include the identification number of the notified body having performed the conformity assessment.
(1) The manufacturer shall submit an application to the notified body for the assessment of the quality management system of the manufacturing process, including the following information:
1) name and address of the manufacturer;
2) relevant information of the medical device or type thereof under conformity assessment;
3) a statement by which the manufacturer guarantees that no application has been submitted to another notified body in regard to the quality management system concerning the same medical device;
4) documentation of the quality management system;
5) commitment of the manufacturer to fulfil the duties associated with the approved quality management system;
6) commitment of the manufacturer to maintain the conformity of the approved quality management system to requirements and the efficiency of the system;
7) if necessary, technical documentation of the approved type and a copy of type examination certificate;
8) statement of the manufacturer to systematically collect information in regard to the medical device and update the information obtained after the manufacturing;
9) statement of the manufacturer to employ measures provided in clause 8 to ensure the necessary improvements in the quality management system and ensure reporting of a risk event upon the occurrence thereof.
(2) An application for assessment of the quality management system of an in vitro diagnostic medical device shall include only technical documentation regarding the approved type and a copy of the type examination certificate.
(3) The application for assessment of the quality management system of an active implantable medical device does not have to include the information provided in clauses 1 and 3 of section 1.
(1) Application of the approved quality management system of manufacturing process shall ensure the conformity of a medical device to the type described in the type examination certificate. All the parts, requirements and terms of the quality management system shall be systematically and regularly documented.
(2) The documentation of the quality management system stated in section 1 shall enable uniform interpretation of the quality policy and quality programmes, plans, manuals and records. The documents shall include the following information:
1) quality goals of the manufacturer;
2) organisation of manufacturing operations, including the organisational structure, responsibility of the management and the extent thereof in regard to the quality of manufacturing and planning;
3) surveillance methods of efficient performance of the quality management system, first of all the capability to achieve the desired quality of planning and the quality of the medical device with the help of the system, including the detection of a medical device not complying with the requirements and in events when the design, manufacturing or final inspection and testing are performed by a third person.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(3) First of all the following information must be submitted about the methods of inspection and quality assurance in manufacturing stage:
1) procedures associated with the acquisition and sterilisation and documents associated with the latter;
2) procedures used for identification of the device based on drawings, specifications and other important documentation in every stage of manufacturing, updating thereof and other important information;
3) tests and series of tests carried out before, during and after the manufacturing, the frequency thereof and the test equipment used;
4) in addition to the provisions of clause 3, it must be possible to detect the calibration of the test equipment.
(4) Clause 4 of section 3 does not apply to the documentation of the quality system of an active implantable medical device.
(1) To determine the conformity to the requirements established in paragraph 33, the notified body assesses the quality management system of the manufacturing process of a manufacturer upon a relevant application by the manufacturer. It is presumed that the relevant quality management systems associated with harmonised standards meet the requirements.
(2) At least one expert with previous experience in assessment of the relevant technology shall participate in the inspection. Inspection shall be connected with the manufacturing location of the manufacturer and in justified events with the location of the supplier of the manufacturer to check the manufacturing process. The manufacturer shall be informed of the results of the inspection.
(3) In the event of inspecting in vitro diagnostic medical devices, the assessment committee shall have a previous experience in assessing the relevant technology.
(4) Inspection of an active implantable medical device is only connected with the production location of the manufacturer.
(1) The manufacturer informs the notified body having approved the quality management system of the manufacturing process of every planned change in the quality management system.
(2) The notified body assesses the planned changes and determines if the quality management system meets the requirements established in § 33 after the implementation of the changes.
(3) The notified body submits its decision to the manufacturer, including the conclusions of the inspection and an assessment with reasons.
(1) The purpose of the surveillance of a quality management system of the manufacturing process is to ensure that the manufacturer fulfils obligations under the approved quality management system with due diligence. The notified body performs surveillance of the application of the quality management system.
(2) The notified body shall organise periodical inspections to ensure the maintenance and application of the quality management system by the manufacturer. If necessary, the notified body may perform tests or have tests performed in order to check the efficient performance of the quality management system. The notified body shall submit an inspection report to the manufacturer of the medical device and in the event of tests a report in regard to the results thereof.
(3) The manufacturer shall allow the notified body to inspect the performance of the quality management system and submit necessary information for that, first of all the following:
1) documents associated with the quality management system;
2) information of manufacturing stages of medical devices under the quality management system, including control, tests, calibration and qualification of the personnel.
(4) Upon the inspection of the quality management system of in vitro diagnostic medical devices, in addition to the information provided in section 3, the manufacturer shall enable access for the notified body to data associated with the design of the relevant medical device, including the results of the analyses, calculations and research.
(5) The notified body may inspect the manufacturer of medical devices without a prior notice. If necessary, upon such an inspection, the notified body may carry out or ask the manufacturer to carry out tests by which the conformity of the quality management system may be checked. After the inspection the notified body shall submit an inspection report and results of possible tests to the manufacturer.
(6) Upon the assessment of the quality of the manufacturing process of an active implantable medical device the notified body shall inform other notified bodies of conformity certificates issued for approved quality management systems, of repealing thereof and of refusal from issuing thereof.
(1) During the quality assurance of the manufacturing process of a medical device belonging to class II a the requirements established in paragraphs 31, 32 and 33 are followed. By drafting a conformity declaration, the manufacturer confirms that the medical devices belonging to class II a are manufactured according to the technical documentation provided in section 2 of § 12 and the requirements thereto based on one sample selection per every subcategory of devices.
(2) Upon choosing the sample selection, the notified body considers the innovation of the technology, similarities of design, technology, manufacturing and sterilisation methods, intended purpose and the previous results of relevant assessments according to the Medical Devices Act (e.g. in regard to physical, chemical or biological properties). The notified body documents the principles of choosing the selection and keeps it accessible for the competent authority.
(3) The notified body assesses the additional selections as a part of the surveillance of the application of the quality management system and keeping it up to date.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
Upon quality assurance of the manufacturing process, the manufacturer informs the notified body always before placing a lot of medical devices containing blood products as inseparable parts thereof on the market, and submits certificates proving the quality and safety of the blood product used in the device issued by a national laboratory or a laboratory assigned by a member state for that purpose in accordance with section 2 of article 114 of Directive 2001/83/EC to the notified body.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(1) For assessment of conformity of an in vitro diagnostic medical device belonging to list A, upon the quality assurance of the manufacturing process the manufacturer shall submit relevant reports regarding the manufactured medical device or a lot thereof to the notified body after the results of the inspections and tests are available.
(2) To ensure the quality of the manufacturing process, the manufacturer shall enable access for the notified body to samples of the manufactured medical device or a lot thereof according to previously agreed conditions and methods.
(1) If the notified body has not informed the manufacturer of a negative decision within the agreed term (but not later than 30 days after the reception of samples of the medical device), the manufacturer may place the in vitro diagnostic medical device belonging to list A on the market.
(2) The notified body shall inform the manufacturer of changing the terms of validity of the design assessment certificate issued during the term provided in section 1.
(1) Quality assurance of the final inspection of a medical device is a procedure according to which the manufacturer carries out the final inspection.
(2) If also the ensuring and preservation of the sterility of a medical device is required during the manufacturing process of the medical device placed on the market as sterile, the conformity assessment shall also include the provisions associated with the quality management system and surveillance of the manufacturing process in addition to that procedure.
(3) By quality assurance of the final inspection of the medical device provided in section 1, the manufacturer confirms that the relevant medical devices comply with the requirements of the Medical Devices Act and the legislation established thereunder.
(4) According to the Medical Devices Act the manufacturer shall place a CE marking on the device and draft a conformity declaration including one or several medical devices manufactured, which are clearly identified by a product name, product code or another explicit reference. The manufacturer shall preserve the conformity declaration.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(5) In addition to the provisions of section 4, the CE marking shall include the identification number of the notified body having performed the conformity assessment.
(1) The manufacturer shall submit an application to the notified body for the assessment of the quality management system of the final inspection of the medical device, including the following information:
1) name and address of the manufacturer;
2) relevant information of the medical device or type thereof under conformity assessment;
3) a statement by which the manufacturer guarantees that no application has been submitted to another notified body in regard to the quality management system concerning the same medical device;
4) documentation of the quality management system;
5) commitment of the manufacturer to fulfil the duties associated with the approved quality management system;
6) commitment of the manufacturer to maintain the conformity of the approved quality management system to requirements and the efficiency of the system;
7) if necessary, technical documentation of the approved type and a copy of type examination certificate;
8) a statement of the manufacturer to systematically collect information in regard to the medical device and update the information obtained after the manufacturing;
9) a statement of the manufacturer to employ measures provided in clause 8 to ensure the necessary improvements in the quality management system and ensure reporting of a risk event upon the occurrence thereof.
(1) Application of the approved quality management system of the final inspection of the medical device shall ensure the conformity of a medical device to the type described in the type examination certificate. All the parts, requirements and terms applicable to the quality management system shall be systematically and regularly documented.
(2) The documentation of the quality management system stated in section 1 shall enable uniform interpretation of the quality policy and quality programmes, plans, manuals and records. The documents shall include the following information:
1) quality goals of the manufacturer;
2) organisation of manufacturing operations, including the organisational structure, responsibility of the management and the extent thereof in regard to the quality of manufacturing and planning;
3) tests and series of tests carried out after the manufacturing, the frequency thereof and the test equipment use;
4) in addition to the provisions of clause 3, it must be possible to detect the calibration of the test equipment;
5) surveillance methods of efficient performance of the quality management system;
6) inspections, tests and calibration performed and qualification of the employees;
7) if the final inspection of the products or parts thereof is performed by a third person, also the surveillance methods according to which the surveillance of the way and extent of efficient performance of the quality management system in regard to the third person takes place.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(3) Inspections provided in section 2 are not applied to the aspects of the manufacturing process designed for ensuring of sterility.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(1) To determine the conformity to the requirements established in paragraph 43, the notified body assesses the manufacturer’s quality management system of the final inspection of a medical device upon a relevant application by the manufacturer. It is presumed that the relevant quality management systems associated with harmonised standards meet the requirements.
(2) At least one expert with previous experience in assessment of the relevant technology shall participate in the inspection. Inspection shall be connected with the manufacturing location of the manufacturer and in justified events with the location of the supplier of the manufacturer to check the manufacturing process. The manufacturer shall be informed of the results of the inspection.
(1) The manufacturer informs the notified body having approved the quality management system of the final inspection of a medical device of every planned change in the quality management system.
(2) The notified body assesses the planned changes and determines if the quality management system meets the requirements established in § 43 after the implementation of the changes.
(3) The notified body submits its decision to the manufacturer, including the conclusions of the inspection and an assessment with reasons.
(1) The purpose of the surveillance of a quality management system of the final inspection of a medical device is to ensure that the manufacturer fulfils obligations under the approved quality management system with due diligence. The notified body performs surveillance of the application of the quality management system.
(2) The notified body shall organise periodical inspections to ensure the maintenance and application of the quality management system by the manufacturer. After the inspection, the notified body shall submit an inspection report to the manufacturer.
(3) The manufacturer shall allow the notified body to inspect the surveillance, control and maintenance measures and submit necessary information for that, first of all the following:
1) documents associated with the quality management system;
2) technical documentation;
3) surveillance reports, information about inspections, calibration and qualification of the personnel.
(4) The notified body may inspect the manufacturer of medical devices without a prior notice. If necessary, upon such an inspection, the notified body may carry out or ask the manufacturer to carry out tests by which the conformity of the quality management system may be checked. After the inspection the notified body shall submit an inspection report and results of possible tests to the manufacturer.
(5) The notified body checks a sufficient number of completed medical devices, verifying if the medical devices meet the requirements established thereto, relying on tests described in relevant harmonised standards or standards equal to those.
(1) During the quality assurance of the final inspection of a medical device belonging to class II a the requirements established in paragraphs 41, 42 and 43 are followed. By drafting a conformity declaration, the manufacturer confirms that the medical devices belonging to class II a are manufactured according to the technical documentation provided in section 2 of § 12 and the requirements thereto based on one sample selection per every subcategory of devices.
(2) Upon choosing the sample selection, the notified body considers the innovation of the technology, similarities of design, technology, manufacturing and sterilisation methods, intended purpose and the previous results of relevant assessments according to the Medical Devices Act (e.g. in regard to physical, chemical or biological properties). The notified body documents the principles of choosing the selection and keeps it accessible for the competent authority.
(3) The notified body assesses the additional selections as a part of the surveillance of the application of the quality management system and keeping it up to date.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
Type examination is a procedure of assessing the conformity of a medical device by which the notified body verifies and confirms the conformity of the inspected medical device to the requirements of the Medical Devices Act and the legislation established thereunder.
(1) The manufacturer shall submit an application for type examination of the medical device to the notified body, including the following information:
1) name and address of the manufacturer;
2) name and address of the authorised representative of the manufacturer, if applicable;
3) documentation based on which it is possible to assess the conformity of the type to the Medical Devices Act and the requirements established thereto;
4) a statement by which the manufacturer guarantees that no application has been submitted to another notified body for assessment of the type of the same medical device.
(2) The notified body may request the types from the manufacturer, if necessary.
(3) The documentation enclosed with the application for type examination shall include information about the design, manufacturing and operation principles, first of all the following:
1) general description of the type, including the descriptions of all planned varieties of the device, and the intended purpose thereof;
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
2) layout drawings, planned manufacturing methods;
3) manufacturing methods associated with the sterilisation of the device;
4) layouts of the parts, components and circuits of the device;
5) descriptions and explanations necessary for understanding the layouts provided in clauses 2 to 4, and the operation of the medical device;
6) references to harmonized standards that have been partly or fully observed during the manufacturing of the device; if harmonized standards have not been fully observed, the solutions applied for following the requirements of the Medical Devices Act and the legislation established thereunder;
7) results of the calculations, risk analysis and risk assessment, research and technical tests of the design;
8) a notice of the content of a blood product or medicinal product in the medical device, as well as information about research carried out for the blood product or a medicinal product during which the safety, quality and efficiency of the blood product or medicinal product were assessed, considering the intended purpose of the device;
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
81) a statement according to Directive No. 2003/32/EC in regard to the device having been or having not been manufactured, using animal tissues;
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
82) measures for liquidation or minimization of dangers associated with the device; [RT I, 07.12.2010, 7 – entered into force 10.12.2010]
9) pre-clinical and clinical assessment;
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
10) labelling design;
11) user manual, if necessary.
(4) The type examination documentation of an in vitro diagnostic medical device shall include the following, in addition to the information provided in clause 1 of section 3:
1) information provided in clauses 2 to 8 of section 2 and 2 to 7 of section 3 of § 12;
2) information provided in section 2 of § 17 for self-testing medical devices.
(5) In addition to the information provided in section 3, the documentation of type examination application of an active implantable medical device shall include information about the medicinal product contained in the device as an inseparable component.
(1) The notified body shall check and assess the documentation provided by the manufacturer and determine the conformity of the medical device thereto. For that, the notified body shall do the following:
1) make a note of the parts of the device the manufacturing of which has or has not followed the relevant provisions of the harmonised standards;
2) check and test the medical device in the manufacturing of which harmonized standards have not been followed to verify the conformity thereof to the requirements;
3) check and test the medical device (or have it checked and tested) manufactured according to the harmonised standards to verify the conformity thereof to the requirements;
4) if it is necessary to connect the medical device with another medical device meeting the characteristics described by the manufacturer in order to use it for the intended purpose, it must be certified that the device meets the requirements to medical devices also after the connection;
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
5) agree the location of tests and inspections with the party having submitted the application.
(2) If the sample of a medical device meets the requirements of the Medical Devices Act and the legislation established thereunder, the notified body issues a type examination certificate to the party having submitted the application, including the following information:
1) name and address of the manufacturer;
2) test results;
3) validity of the certificate;
4) identification data of the type of device.
(3) Accompanying documents shall be enclosed with the type examination certificate, the copies of which remain with the notified body.
(4) Before providing the final assessment of the design, the notified body consults the following parties in order to verify the quality, safety and efficiency of the substance included in the device:
1) one competent authority appointed by the member states or the EMA, if the medical device contains a medicinal product as an inseparable component under the Medicinal Products Act;
2) the EMA, if the medical device contains a blood product as an inseparable component under the Medicinal Products Act.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(5) A competent institution of EMA shall draft an opinion within 210 days from receiving the valid documents. The scientific opinion of a competent institution or EMA shall be enclosed with the documents regarding the device. The notified body considers the above described opinion and in regard to devices provided in clause 2 of section 4 does not issue an assessment certificate of the design, if it contradicts the opinion of EMA. The notified body submits its final decision to a competent authority having provided the opinion.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(6) In the event of devices manufactured of tissues of animal origin provided in Directive 2003/32/EC of the Committee, the notified body follows the procedures established in the Directive.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(1) The manufacturer or an authorised representative thereof shall inform the notified body having issued the type certificate of every significant change implemented in the medical device that may influence the conditions of use of the medical device or the conformity of the medical device to the requirements of the Medical Devices Act and the legislation established thereunder.
(2) The notified body issues an annex to the type certificate for a medical device with approved changes.
(3) A manufacturer of in vitro diagnostic medical device shall inform the notified body immediately of all known changes in infection markers or pathogens, especially changes based on biological variability and complexity. The manufacturer shall inform the notified body of all known probable influences of the changes in regard to the operation of in vitro diagnostic medical device.
(4) In justified events, the notified body shall enable access of other notified bodies and competent authorities to the type certificate issued and annexes thereto, having first informed the manufacturer of the relevant medical device.
Conformity certification is a procedure of assessment of the conformity of a medical device by which the manufacturer or an authorised representative thereof confirms that the medical device having passed the procedure of type examination meets the type described in the type certificate and complies with the requirements of the Medical Devices Act and the legislation established thereunder.
(1) The manufacturer shall apply all the necessary measures to ensure the conformity of the medical device to the type described in the type certificate by the manufacturing process, as well as with the requirements of the Medical Devices Act and the legislation established thereunder.
(2) Before starting the manufacturing, the manufacturer shall prepare the documents describing the manufacturing process, describing the manufacturing stages associated with sterilisation separately.
(3) The documents shall include information regarding the precautions used in the daily manufacturing process, ensuring production with uniform quality and the conformity of the medical device to the type described in the type certificate and the requirements of the Medical Devices Act and the legislation established thereunder.
(4) In addition to the provisions in section 2, the manufacturer shall prepare documents proving the suitability of the source material used in the manufacturing of in vitro diagnostic medical devices, and, if necessary, determine the control procedures based on modern equipment for proving the conformity to the requirements.
(5) If certain manufacturing stages of a medical device placed on the market as sterile are planned for the preservation and ensuring of sterility, the manufacturer shall additionally apply provisions associated with the quality management system and surveillance of the manufacturing process.
(6) The manufacturer of a medical device shall systematically check the information obtained in the post-manufacturing stage. According to the information received, the manufacturer shall apply appropriate measures for bringing the manufacturing and the medical device into conformity to the requirements of the Medical Devices Act and the legislation established thereunder, and inform of a risk event, if one arises.
(1) The notified body shall organise suitable inspections and tests according to the selection of the manufacturer to verify the conformity of the device to the requirements of the Medical Devices Act and the legislation established thereunder. It shall do the following:
1) inspect and test every device separately, or
2) inspect and test medical devices on the basis of statistics.
(2) The notified body shall apply the testing, surveillance and control methods of the manufacturing process created by the manufacturer and approved by the notified body in conformity certification of an in vitro diagnostic medical device. In the event of conformity certification of an in vitro diagnostic medical device, inspections and tests provided in section 1 shall be applied in the extent also applicable to final tests.
(3) Section 1 shall not be applied for the stages of manufacturing process designed for ensuring the sterility of a medical device.
(1) To verify the conformity of a medical device to the type described in a relevant type certificate and the requirements of the Medical Devices Act and the legislation established thereunder, the medical device shall pass tests provided in the harmonised standards or equal thereto.
(2) The notified body shall place an identification number on each approved medical device and draft a conformity certificate based on the tests performed. Also a person authorised by the notified body may place the identification number on behalf of the notified body.
(1) Statistical conformity certification of a medical device is a part of conformity certification performed by the notified body in order to verify the conformity of the medical device and a lot thereof to the type described in the type certificate and the requirements of the Medical Devices Act and the legislation established thereunder.
(2) For statistical conformity certification, the manufacturer shall submit medical devices to the notified body in lots, from which random samples are selected for testing according to the requirements of harmonised standards or standards equal thereto.
(3) [Repealed - RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(4) [Repealed - RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(41) Upon statistical conformity certification of a lot of medical devices, the samples are determined according to variables and characteristics ensuring high capacity of safety and function considering the level of the equipment.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(5) In application of methods for forming the sample described in harmonised standards the type differences of the relevant medical device are considered.
(1) Statistical inspection of the properties of an in vitro diagnostic medical device and variations thereof is based on the characteristics of the device ensuring high-level safety and operation of the device based on the development of modern technology.
(2) In the event of statistical conformity assessment of an in vitro diagnostic medical device the notified body shall decide with the manufacturer if the statistical method is applied to lots or to a single lot.
(1) The notified body shall place an identification number on each approved medical device and draft a conformity certificate based on the statistical tests performed. Also, a person authorised by the notified body may place the identification number on behalf of the notified body. All the devices belonging to the lot of statistically tested medical equipment may be placed on the market, excluding the non-compliant devices included in the sample.
(2) If a lot does not comply with the requirements, the notified body shall apply the necessary measures to prevent the placement of the lot on the market. In the event of frequent non- conformity of lots the notified body may suspend the statistical conformity certification.
In quality assurance of a medical device belonging to class II a, the requirements of paragraphs 52, 53, 55, 56 and 58 are followed. By drafting a conformity declaration, the manufacturer confirms that the medical devices belonging to class II a are manufactured according to the requirements to the technical documentation provided in section 2 of § 12 and the devices.
The manufacturer informs the notified body before placing a lot of medical devices containing blood products as inseparable parts thereof on the market, and submits documentation proving the quality and safety of the blood product used in the medical device issued by a national laboratory or a laboratory assigned by a member state for that purpose in accordance with section 2 of article 114 of Directive 2001/83/EC.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(1) Statement is a document by which the manufacturer or an authorised representative certifies that the medical device complies with the requirements of the Medical Devices Act and the legislation established thereunder. A statement is drafted for:
1) a custom-made medical device;
2) a clinically studied medical device;
3) and for a medical device for operational assessment.
(2) A statement drafted for a medical device includes the identification of the relevant medical device.
A manufacturer shall manufacture medical devices according to the documentation provided in the statement.
(1) A statement for a custom-made medical device includes the following information:
1) a statement that the device is designed for a particular patient;
2) name of the patient;
3) name of the health care professional or another professional user according to whose order the custom-made medical device was manufactured, and the name of the health care provider, if necessary;
4) special properties of the device based on the order;
5) a statement that the device complies with the requirements of the Medical Devices Act and the legislation established thereunder;
6) reference to manufacturing stages where the prescribed requirements were not followed, including the reasons;
7) name and address of the manufacturer.
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(2) Upon a relevant request of a competent authority, a manufacturer of a custom-made medical device shall enable access to the following documents accompanying a custom-made medical device:
1) design and description of the device;
2) description of the manufacturing and operation enabling the assessment of conformity of the device to the requirements of the Medical Devices Act and the legislation established thereunder;
3) information about the location of manufacturing. [RT I, 07.12.2010, 7 – entered into force 10.12.2010]
(1) A statement of a clinically studied medical device includes the following information:
1) identification information;
2) plan of the clinical study, brochure of the person in charge of the study, statement about the insurance of persons participating in the study, informed consent form of patient, a notice whether the medical device contains a medicinal product or blood product as an inseparable component under the Medicinal Products Act, and a notice whether the device has been or has not been manufactured, using animal tissues according to the Directive No. 2003/32/EC of the Commission;
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
3) approval of the ethics committee;
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
4) name of the health care professional or another professional user and the institution responsible for the performance of the studies;
5) location, start time and scheduled duration of the study;
6) a statement that the device meets the requirements of the Medical Devices Act and the legislation established thereunder also in the extent not subject to the study;
7) a statement that all precautions have been taken in order to ensure the safety and health protection of the patient, user and other persons.
(2) Upon a relevant request of competent authorities, the manufacturer shall enable access to the following documentation accompanying the clinically studied medical device:
1) general description and intended purpose of the device; [RT I, 07.12.2010, 7 – entered into force 10.12.2010]
2) layout drawings and manufacturing methods, layout, descriptions and explanations of the parts, accessories, etc. necessary to understand the principles of operation of those and the relevant device;
3) results of risk analysis and references to harmonized standards that have been partly or fully observed during the manufacturing of the device; if harmonized standards have not been fully observed, the measures applied for following the requirements of the Medical Devices Act and the legislation established thereunder;
31) if the device contains a medicinal product or a blood product as an inseparable component, information about the tests carried out in regard thereto for assessment of the safety, quality and efficiency of the relevant substance or blood product considering the intended purpose of the device;
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
32) if the device has been manufactured, using animal tissues according to Directive No. 2003/32/EC of the Commission, the measures applied to decrease the risk of infection in connection therewith;
[RT I, 07.12.2010, 7 – entered into force 10.12.2010]
4) design calculations and results of inspections by the manufacturer.
(3) The manufacturer shall apply measures to ensure the conformity of the medical devices manufactured during the manufacturing process to the documentation provided in section 2. If necessary, the manufacturer shall have the efficiency of the above described measures assessed or inspected.
(1) A statement for a medical device for assessment of performance includes the following information:
1) identification information of a medical device for assessment of performance;
2) a study plan including the purpose of the study, scientific, technical or medical reasons, extent of the study and the number of medical devices to be clinically studied;
3) a list of laboratories or other institutions associated with the study;
4) start time and scheduled duration of the assessment;
5) in the event of self-testing medical devices the number and places of residence of regular users associated with the performance assessment of the relevant medical device.
(2) In addition to the information provided in section 1, the manufacturer shall confirm the conformity of the medical device to the requirements of the Medical Devices Act and the legislation established thereunder also for the part not included in the scope of the study of the relevant medical device, which is separately provided in the statement.
(3) The manufacturer submits a statement that all precautions have been applied in order to ensure the safety and protection of health of the patient, user and other persons.
1Directive No. 90/385/EEC of the European Council on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.07.1990, pages 17–36), amended by Directive 93/42/EEC (OJ L 169, 12.07.1993, page 1) and Directive 93/68/EEC (OJ L 220, 30.08.1993, page 1) and Directive 2007/47/EC (ELT L 247, 21.9.2007, pages 21–55) and as amended by Directive 90/358/EEC (OJ L 7, 1.11.1994, page 20); Directive No. 93/42/EEC of the European Council on medical devices (OJ L 169, 12.07.1993, pages 1–43), as amended by Directive 98/79/EC (OJ L 331, 7.12.1998, page 1), by Directive 2000/70/EC (OJ L 313, 13.12.2000, page 22) and Directive 2001/104/EC (OJ L 6, 10.01.2002, page 50); Directive 98/79/EC of the European Parliament and Council on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, pages 1–37), as amended by Directive 98/79/EC (OJ L 22, 29.01.1999, page 75) and Directive 98/79/EC (OJ L 6, 10.01.2002, page 70). [RT I, 07.12.2010, 7 – entered into force 10.12.2010]
