Government Decree No. 245 / 2009 Coll.
Government Regulation amending Government Decree No. 336 / 2004 Coll., laying down technical requirements for medical devices and amending Government Decree No. 251 / 2003 Coll., amending certain Government Regulations issued for the implementation of Act No. 22 / 1997 Coll., on Technical Requirements for Products and amending and supplementing certain acts, as amended, as amended by Government Decree No. 212 / 2007 Coll.
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05.08.2009
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245
GOVERNMENT REGULATION
of 13 July 2009
amending Government Regulation No 336 / 2004 Coll., laying down technical requirements for medical devices and amending Government Regulation No 251 / 2003 Coll., amending certain government regulations issued for the implementation of Act No 22 / 1997 Coll., on technical requirements for products and amending and supplementing certain laws, as amended, as amended by Government Regulation No 212 / 2007 Coll.
The Government directs pursuant to Section 22 of Act No. 22 / 1997 Coll., on technical requirements for products and on the amendment and addition of certain laws, as amended by Act No. 71 / 2000 Coll. and Act No. 205 / 2002 Coll., ("the Act ') to implement § 11 paragraphs 1 and 2, § 11a paragraphs 2, § 12 and 13 of the Act and to implement Act No. 123 / 2000 Coll., on medical devices and on the amendment of certain related laws, as amended by Act No. 130 / 2003 Coll., Act No. 274 / 2003 Coll. and Act No. 58 / 2005 Coll. (" the Act on Medical Devices'):
Government Decree No. 336 / 2004 Coll., laying down technical requirements for medical devices and amending Government Decree No. 251 / 2003 Coll., amending certain Government Regulations issued for the implementation of Act No. 22 / 1997 Coll., on Technical Requirements for Products and amending and supplementing certain acts, as amended, as amended by Government Decree No. 212 / 2007 Coll., is amended as follows:
1. At the end of footnote 1, the sentence "Directive 2007 / 47 / EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90 / 385 / EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93 / 42 / EEC on medical environments and Directive 98 / 8 / EC on the placing of biocidal products on the market 'is added.
2. in Paragraph 2 (2) (a), including footnote 5,
"(a) medicinal products5); When deciding whether a product falls within the scope of the Act on Medication5) or of this Government Regulation, account shall be taken in particular of the main mode of action of the product,
5) Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Law on Medicines), as amended. '.
3. in Article 2 (2) (c):
"(c) transplants or tissues or cells of human origin and products containing or derived from tissues or cells of human origin, with the exception of medical devices referred to in Article 2 (2) (g) of the Law on medical devices,"
4. in Article 2 (2), point (e) shall be deleted;
Point (f) shall be renumbered as point (e).
5. In Article 4, at the end of paragraph 1, the sentence "Medical devices which are simultaneously machinery (8a) shall also comply with the essential health and safety requirements set out in Annex 1 to the Government Regulation on Technical Requirements for Machinery (8a), provided that these essential health and safety requirements are more specific than those set out in Annex 1 to this Regulation. ';
(6) footnote 8a reads as follows:
"(8a) Government Decree No. 176 / 2008 Coll., on Technical Requirements for Machinery. '
7. Paragraph 4 (5) reads as follows:
"(5) A custom medical device (15) may be placed on the market and put into service if conformity has been assessed in accordance with Article 9 (5) and Annex 8 to this Regulation. The special medical devices of Classes IIa, IIb and III shall be accompanied by the declaration set out in Annex 8 to this Regulation, available to a particular patient. ';
8. footnote 18 reads as follows:
"18) Government Decree No. 616 / 2006 Coll., on technical requirements for products in terms of their electromagnetic compatibility."
9. In Section 4, paragraph 10 is added:
"(10) Where the product is intended to be used by the manufacturer as a personal protective device (7) and at the same time as a medical device within the meaning of this Regulation, it shall also comply with the relevant essential health and safety requirements under the Government Regulation laying down technical requirements for personal protective equipment (7). ';
10.Paragraph 6 (1) reads as follows:
"(1) If there is a reasonable suspicion that the CE marking has been affixed to the medical device unjustly or is missing, this shall be done in accordance with the specific legislation19). '
11. in Paragraph 7 (2):
"(2) If the Ministry concludes that:
(a) the application of the classification rules set out in Annex 9 to this Regulation requires a decision on the classification of a particular medical device or category of medical devices;
(b) a particular medical device or category of medical devices should be classified in another class by way of derogation from the provisions of Annex 9 to this Regulation;
(c) the conformity of a medical device or category of medical devices should be assessed only in accordance with 1 of the procedures set out in Section 9;
(d) it is necessary to decide whether a particular product or product group complies with any of the definitions in Section 2 of the Health Devices Act; or
(e) the classification rules set out in Annex 9 to this Regulation require adaptation for reasons of technical progress or information that becomes available in the adverse event log system;
request the Commission of the European Communities to take the necessary measures; the request must be duly substantiated. ';
12. in Article 10 (4), the words "Annexes No 2 and No 3" shall be replaced by the words "Annexes No 2, 3, 5 and 6" and the words "for a further 5 years" shall be replaced by "for a further period of no more than 5 years each time."
13. in Section 11, the heading reads: "Specific procedure for medical devices systems and kits and for carrying out sterilisation of medical devices."
14. in Article 11 (4), "Annexes 4, 5 or 6" is replaced by "Annexes 2 or 5" and the second sentence is replaced by "The use of those Annexes and the activity of the notified person is limited to the procedure necessary to achieve sterility lasting until the sterile packaging is opened or damaged."
15. in Article 11 (5), the second sentence shall be replaced by "The declaration referred to in paragraphs 2 and 4 shall be kept by the person referred to in paragraphs 1 to 4 for at least 5 years for the purposes of the competent administrative authorities."
16. Paragraph 13, including the title, reads:
Notification obligation of persons responsible for placing medical devices on the market or putting into service
(1) A manufacturer who, in accordance with the procedures laid down in Article 9, places medical devices on the market under his name, authorised representative and person involved in the activities referred to in Article 11, shall inform the Ministry, prior to placing on the market, of the address of his registered office and establishment, if any, of the legal person, or of the address of his establishment and residence or, where applicable, of the place of business, if different from his place of residence, the natural person and, at the same time, the description of the relevant medical devices.
(2) For medical devices of classes IIa, IIb and III, the Ministry may require from the person putting the medical device into service in the Czech Republic information enabling identification of the medical device, its designation and instructions for use.
(3) Where a manufacturer intending to place on the market under his name a medical device referred to in paragraph 1 or 2 does not have:
(a) the seat, if any, of the legal person
(b) the place of residence or place of business, if different from the place of residence, if it is a natural person;
in any of the Member States of the European Communities, appoint an authorised representative to place such medical devices on the market who is its sole authorised representative within the European Communities.
(4) The Ministry shall, upon request, communicate to the other Member States of the European Communities and to the Commission of the European Communities the information resulting from paragraphs 1 to 3 provided by the manufacturer or his authorised representative. "
17. in Article 15 (1) and (2):
"(1) For medical devices intended for clinical examinations, the manufacturer or authorised representative shall proceed as specified in Annex 8 to this Regulation and notify the Ministry of the intention to carry out clinical examinations by means of the declaration referred to in point 2.2 of Annex 8 to this Regulation.
(2) For Class III medical devices and implantable medical devices and invasive medical devices of Class IIa and IIb with long-term use, clinical examinations of the medical device may be initiated after 60 days after their notification in accordance with paragraph 1, unless the Ministry notifies them of its non-compliance within that period for reasons of public health or public interest. Such tests may be initiated, with the agreement of the Ministry, before the 60-day period expires, if the Ethics Committee concerned has given a positive opinion on the programme of such tests, including a review of the clinical trial plan. ';
18. In Article 15 (3), the words "evaluation or clinical evaluation 'are deleted.
19. Paragraph 15 (5) reads:
"(5) In the case of medical devices not referred to in paragraph 2, clinical trials may be initiated with the consent of the Ministry immediately after notification, provided that the Ethics Committee concerned has given a positive opinion on the test programme, including a review of the clinical trial plan. ';
20. In Article 15, the following paragraph 6 is added:
"(6) The manufacturer or his authorised representative shall notify the Ministry of the cessation of the clinical trial, including its justification in the event of early termination. If the clinical trial is terminated prematurely for safety reasons, the Ministry shall forward this notification to all Member States of the European Communities and to the Commission of the European Communities. The manufacturer or authorised representative shall keep the report referred to in Section 12 of the Medical Devices Act available to the competent authorities. ';
21. Paragraph 16 (5) reads:
"(5) The nominated person shall inform all issued, modified, supplemented, suspended and withdrawn certificates as well as the refusal to issue the certificate, the Office and the Ministry and the suspended and withdrawn certificates and the refusal to issue the certificate shall inform the other notified persons. Such notified persons shall also inform on request of certificates issued. The notified person shall also make available any other relevant information upon request. ';
22. In Annex 1, point 1 is replaced by the following:
"1. Medical devices shall be designed and manufactured in such a way that, when used under the specified conditions and for the intended purpose, they do not jeopardise the clinical condition or safety of patients, nor the safety and health of users or, where appropriate, other persons, provided that all risks which may be associated with the intended use of such devices are acceptable compared to their benefit to the patient and correspond to a high level of health and safety. This includes:
1.1. Reduction, where possible, of the risk of error in use due to the ergonomic properties of the medical device and the environment in which the medical device may be used (patient safety proposal); and
1.2. Consideration of technical knowledge, experience, education and training and, where appropriate, the health and physical condition of the users for whom the medical device is intended (proposal for lay, professional, disabled or other users). ';
23. In Annex 1, point 6a is inserted after point 6:
"6a. The demonstration of compliance with the essential requirements shall include the clinical evaluation referred to in Annex 10 to this Regulation. ';
24. In Annex 1, point 7.1.2 is replaced by the following:
"7.1.3. results of biophysical or model research, the validity of which has already been demonstrated. ';
25. in Annex 1, point 7.4.:
"7.4. Provisions for medical devices with an integrated medicine or a human blood derivative.
7.4.1. If a medical device contains, as an integral part of it, a substance which may be considered as a medicinal product under a specific legislation5) and which may act on the body as an additional effect to the effect of the medical device, the quality, safety and usefulness of that substance shall be verified by analogy using the methods specified in the specific legislation5).
7.4.2. For the substances referred to in point 7.4.1, after verifying the usefulness of the substance as part of a medical device and taking into account the intended purpose of use of the medical device, the notified person shall request a technical opinion on the quality and safety of the substance, including a clinically verified risk, when integrating the substance into the medical device from one of the competent authorities of the Member States of the European Communities or from the European Medicines Agency (EMEA). Where a professional opinion is requested by the Institute, it shall take into account the production process and the information on the usefulness of the inclusion of the substance in the medical device, as indicated by the notified person.
7.4.3. Where a medical device contains, as an integral part, a human blood derivative, the notified person shall, after verifying the usefulness of the human blood derivative as part of the medical device and taking into account the intended purpose of the medical device, request the EMEA's expert opinion on the quality and safety of the human blood derivative, including the clinically verified risk of the incorporation of the human blood derivative into the medical device.
7.4.4. Where changes are made to a substance incorporated into a medical device, in particular as regards its manufacturing process, the notified person shall be informed of the changes and shall request the competent authority responsible for the medicinal products (i.e. the authority which issued the original professional opinion) to confirm that the quality and safety of the complementary substance is maintained. Where a professional opinion is requested by the Institute, it shall take into account the information on the usefulness of the inclusion of the additional substance in the medical device, as indicated by the notified person, to ensure that the changes have no negative impact on the identified risk when the substance is incorporated into the medical device.
7.4.5. Where the Institute, as the competent authority responsible for the original expert opinion, receives information on the additional substance that could affect the identified risk when integrating the additional substance into the medical device, it shall inform the notified person whether the information has an impact on the specified risk when integrating the additional substance into the medical device or not. The notified person shall take into account the updated expert opinion when reassessing his conclusion from the conformity assessment procedure. ';
26. In Annex 1, point 7.5, including footnote 25a:
"7.5. Medical devices shall be designed and manufactured in such a way as to minimise the risks caused by substances leaking from medical devices. Particular attention shall be paid to substances carcinogenic, mutagenic or toxic to reproduction within the meaning of the Chemicals Act 25a).
Where parts of a medical device or medical devices as a whole intended for the administration or disposal of medicinal products, bodily fluids or other substances into or out of the body, or medical devices intended for the transport and storage of such bodily fluids or other substances, contain phthalates classified as carcinogenic, mutagenic or toxic to reproduction of category 1 or 2 within the meaning of the Chemicals Act 25a), such medical devices shall be labelled on the medical device itself or on the packaging of each unit or, where appropriate, on the packaging as a medical device containing phthalates.
Where the intended use of these medical devices involves the treatment of children or pregnant or breast-feeding women, the manufacturer shall provide specific justification for the use of such substances in the technical documentation, taking into account compliance with the essential requirements, in particular this point, and in the instructions for use, to provide information on residual risks for those patient groups and, where possible, appropriate preventive measures.
25a) Act No. 356 / 2003 Coll., on Chemicals and Chemicals and amending and supplementing certain laws, as amended. '
27. in Annex 1, point 13.1., the first sentence is replaced by the following: "Each medical device shall be provided with the information necessary for its safe and correct use, taking into account the training and knowledge of potential users and the identification of the manufacturer."
28. in Annex 1, point 13.3.1 shall read:
"13.3.1. the name and, where applicable, the name and surname of the manufacturer, the address of his place of business, if the manufacturer is a natural person; the name or business name, address of the registered office if the manufacturer is a legal person; in the case of medical devices imported into the European Communities, provided that they are distributed within the European Communities, the label or label, the outer packaging or the instructions for use shall, in addition, include the name and, where appropriate, the surname or surname or business name or business name and the address of the place of business or registered office of the authorised representative, if the manufacturer does not have his registered office in the Member State of the European Communities; ';
29. in Annex 1, point 13.3.2 shall read:
"13.3.2. the detailed information which the user necessarily needs to identify the medical device and the contents of the package, ';
30. in Annex 1, point 13.3.6. read:
"13.3.6. where applicable, indication that it is a medical device for 1 use. The manufacturer's information that it is a medical device for 1 use must be uniform within the European Communities, '.
31. In Annex 1, point 13.6.8. is replaced by the following: "If a medical device is designated as a medical device for 1 use, the instructions shall include information on known properties and technical factors of the medical device known to the manufacturer and likely to pose a risk when the medical device is re-used. If the instructions for use are not required according to point 13.1, this information shall be made available to the user on request, '.
32. in Annex 1, point 13.6.15 reads:
"13.6.15. information on active substances or human blood derivatives contained in a medical device as an integral part thereof in accordance with point 7.4. ';
33. In Annex 1, point 13.6.16 is replaced by the following:
"13.6.17. date of issue of the last revision of the instructions for use. ';
34. in Annex No 1, point 14 is deleted;
35. in Annex No 2, points 1 and 2 read:
"1. The manufacturer shall ensure the establishment and operation of a quality system approved for the design, manufacture and exit checks of the relevant medical devices referred to in point 3; the quality system shall be subject to the audit referred to in points 3.3 and 4 and shall be supervised in accordance with point 5.
2. the EC declaration of conformity (Quality Assurance System) is the procedure whereby a manufacturer who fulfils the obligations referred to in point 1 ensures and declares that the medical devices concerned comply with the provisions of this Regulation which apply to them.
Manufacturer
2.1. The medical devices bear the CE marking in accordance with Section 5; and
2.2 draws up a written declaration of conformity which it is obliged to keep; This declaration shall be drawn up for 1 or more medical devices manufactured clearly identified by the name of the medical device, the code of the medical device or any other unambiguous reference. ';
36. In Annex 2, point 3.1.7, including footnote 30, reads:
"3.1.7. a commitment by the manufacturer to implement and update the systematic procedure for evaluating the experience gained with manufactured medical devices, including the provisions set out in Annex 10 to this Regulation, and to implement the necessary corrective measures in an appropriate manner; Part of this commitment is the obligation of the manufacturer to notify the Institute of adverse events under the Health Devices Act (30) as soon as it becomes aware of them.
30) § 3 (g) of Act No. 123 / 2000 Coll., as amended. '
37. in Annex No 2, point 3.2, the following paragraph is inserted in the introductory part of the provisions after the second paragraph: "This includes the relevant documentation, data and records resulting from the procedures referred to in point 3.2.3."
38. In Annex No 2, the following point 3.2.2.3 is inserted after point 3.2.2.2:
"3.2.2.3. Where the design, manufacture or exit control and testing of medical devices or parts thereof are carried out by a third party, methods of monitoring the effective functioning of the quality system and the manner and extent of control carried out over the third party, ';
39. in Annex 2, point 3.2.3. read:
"3.2.3. procedures for monitoring and verifying the design of medical devices, including appropriate documentation, in particular:
3.2.3.1. a general description of the medical device, including all planned options, and its intended uses,
3.2.3.2. the design specifications, including the standards to be applied, the results of the risk analysis and a description of the solutions adopted to meet the essential requirements applicable to the medical devices, unless the standards referred to in Section 4 (2) are fully applied,
3.2.3.3. Techniques used for design control and verification and procedures and systematic measures to be used in the design of medical devices,
3.2.3.4. where a medical device is to be connected to another medical device or medical device for the intended operation, it must be demonstrated that it meets the essential requirements when it is attached to such medical device or medical devices having the characteristics specified by the manufacturer,
3.2.3.5. a statement as to whether a medical device contains, as an integral part of, the substance or human blood derivative referred to in point 7.4. of Annex 1 to this Regulation, and the test data required in this context to assess the safety, quality and usefulness of that substance or human blood derivative, taking into account the intended purpose of the medical device;
3.2.3.6. a statement as to whether the medical device is manufactured using tissues of animal origin within the meaning of § 1 (b);
3.2.3.7. the solutions adopted as set out in point I.2. of Annex 1 to this Regulation,
3.2.3.8. preclinical evaluation,
3.2.3.9. the clinical trial referred to in Annex 10 to this Regulation,
3.2.3.10. design of the marking and, where appropriate, instructions for use, ';
40. In Annex No 2, point 3.3, the third and fourth sentences are replaced by the sentences "At least 1 member experienced in assessing the technology of the medical device shall be in the team responsible for quality assessment. The assessment shall include an assessment of the documentation of the design of the medical device concerned on a representative basis, an inspection of the production processes at the manufacturer's operating premises and, where appropriate, a check of the production processes at the suppliers' or other contractors' premises. ';
41.3 In Annex 2, point 4.3 reads as follows:
"4.3. Scope of the notified person
4.3.1. The notified person shall review the application and, if the medical device complies with the provisions of this Regulation, issue an EC design review certificate to the applicant. The notified person may, at his discretion, request additional tests or evidence to enable him to assess the conformity of the medical device with the requirements of this Regulation. The EC design examination certificate shall contain the conclusions of the examination, the conditions of validity of the certificate, the data necessary to identify the approved design of the medical device and, where appropriate, a description of the intended purpose of use.
4.3.2. In the case of medical devices referred to in point 7.4.2 of Annex No 1 to this Regulation, the notified person, in accordance with point 7.4.2 of Annex No 1 to this Regulation, shall, before taking a decision on a professional opinion, request one of the competent authorities of the Member States of the European Communities or the EMEA. Where a professional opinion is requested by the Institute, it shall draw up a professional opinion within 210 days of the date of receipt of the complete dossier. The professional opinion of the competent authority of the Member State of the European Communities or the EMEA shall be included in the medical device documentation. When taking decisions, the person nominated shall pay due attention to the expert opinion and communicate his final decision to the competent authority which issued the expert opinion.
4.3.3. In the case of medical devices referred to in point 7.4.3 of Annex 1 to this Regulation, the EMEA 's expert opinion shall be included in the dossier for the medical device. When taking decisions, the person nominated shall pay due attention to the EMEA' s expert opinion. A person must not issue a certificate if the EMEA 's professional opinion is unfavourable. They shall communicate their final decision to the EMEA.
4.3.4. In the case of medical devices referred to in Article 1 (b) manufactured using tissues of animal origin, the notified person shall comply with the procedures laid down in Article 12. ';
42. In Annex 2, point 5.2.2. read:
"5.2.2. the data required in the design section of the quality system, such as the results of analyses, calculations, tests, solutions adopted as set out in Part I. (2) of Annex 1 to this Regulation, preclinical and clinical evaluation, post-marketing follow-up plan and, where appropriate, post-marketing follow-up results, ';
43. In Annex 2, point 6.1 shall read:
"6.1. The manufacturer of a medical device, or his authorised representative, shall keep for at least 5 years and, in the case of implantable medical devices, for at least 15 years from the date of manufacture of the last medical device at the disposal of the competent authorities of the State
6.1.1. a written declaration of conformity,
6.1.2. Documentation of the quality system referred to in point 3.1.4 of this Annex, and in particular documentation, data and records arising from the procedures referred to in point 3.2.3.,
6.1.3. Documentation of amendments according to paragraph 3.4.
6.1.4. Documentation according to paragraph 4.2.
6.1.5. certificates and other documents of the notified person referred to in points 3.3, 3.4, 4.3, 4.4 and 5.3. ';
44. Point 7 of Annex 2 reads as follows:
'7. Use for medical devices of Classes IIa and IIb
7.1. In accordance with § 9 (2) and (3), this Annex may apply to medical devices of Classes IIa and IIb. However, point 4 shall not apply.
7.2. As regards Class IIa medical devices, the notified person shall assess as part of the evaluation referred to in point 3.3 the technical documentation of at least 1 representative sample from each subset of medical devices as described in point 3.2.3 in order to assess compliance with the provisions of this Regulation.
7.3. As regards Class IIb medical devices, the notified person shall assess as part of the evaluation referred to in point 3.3 the technical documentation of at least 1 representative sample from each generic medical device group as described in point 3.2.3, in order to assess compliance with the provisions of this Regulation.
7.4. When selecting a representative sample or samples, the notified person shall take into account the novelty of the technology, the similarity of design, technology, methods of production and sterilisation, the intended use and the results of all previous related assessments (e.g. taking into account physical, chemical or biological characteristics). The notified person shall document and retain at the disposal of the competent authorities the reasons for the selection of the sample or samples.
7.5. Further samples shall be assessed by the notified person as part of the surveillance referred to in point 5. ';
45. In Annex 2, footnote 26 reads:
"26) Act No. 378 / 2007 Coll. '.
46. In Annex 3, point 3 reads as follows:
'3. The documentation shall allow for an understanding of the design, manufacture and performance of the medical device and shall include in particular:
3.1. The overall description of the type, including all planned variants, and its intended uses,
3.2. Design drawings, envisaged production technologies, in particular with regard to sterilisation, and schematics of components, sub-assemblies, circuits, etc.,
3.3. Descriptions and explanations needed to understand the above drawings of the schemes and the functioning of the medical device,
3.4. a list of the standards referred to in Section 4 (2) applied in full or in part and a description of the solutions adopted to meet the essential requirements, unless the standards referred to in Section 4 (2) are fully applied,
3.5. Results of design calculations carried out, risk analysis, research, technical tests, etc.,
3.6. a statement as to whether the medical device contains, as an integral part, a substance or a human blood derivative as referred to in point 7.4. of Annex 1 to this Regulation and the test data required in this context to assess the safety, quality and usefulness of that substance or human blood derivative, taking into account the intended purpose of the medical device;
3.7. a statement as to whether a medical device is manufactured using tissues of animal origin, within the meaning of § 1 (b);
3.8. the solutions adopted, as referred to in point I.2. of Annex 1 to this Regulation,
3.9. preclinical evaluation,
3.10. the clinical trial referred to in Annex 10 to this Regulation,
3.11. design of marking and, where appropriate, instructions for use. ';
47. In Annex 3, points 4.5 and 4.6 are deleted.
48. Point 5 of Annex 3 reads as follows:
"5. Conditions for the issue of documents by a notified person
5.1. Where a type complies with the provisions of this Regulation, the notified person shall issue the applicant with an EC type-examination certificate. The EC type-examination certificate shall be accompanied by the relevant parts of the dossier, the copy of which shall be kept by the notified person. The EC type-examination certificate shall contain:
5.1.1. the name and, where applicable, the name and surname of the manufacturer, the address of his place of residence and the place of business where the manufacturer is a natural person living abroad, the name and, where applicable, the name, and surname, the address of the manufacturer's permanent residence if he is resident in the Czech Republic; the business name, registered office and address of the establishment, if any;
5.1.2. the conclusions of the assessment, the conditions of validity and the data needed to identify the approved type.
5.2. In the case of medical devices referred to in point 7.4.2 of Annex No 1 to this Regulation, the notified person, in accordance with point 7.4.2 of Annex No 1 to this Regulation, shall, before taking a decision on a professional opinion, request one of the competent authorities of the Member States of the European Communities or the EMEA. Where a professional opinion is requested by the Institute, it shall draw up a professional opinion within 210 days of the date of receipt of the complete dossier. The professional opinion of the competent authority of the Member State of the European Communities or the EMEA shall be included in the medical device documentation. When taking decisions, the person nominated shall pay due attention to the expert opinion and communicate his final decision to the competent authority which issued the expert opinion.
5.3. In the case of medical devices referred to in point 7.4.3 of Annex 1 to this Regulation, the EMEA 's expert opinion shall be included in the dossier for the medical device. When taking decisions, the person nominated shall pay due attention to the EMEA' s expert opinion. A person must not issue a certificate if the EMEA 's professional opinion is unfavourable. They shall communicate their final decision to the EMEA.
5.4. In the case of medical devices referred to in § 1 (b) manufactured using tissues of animal origin, the notified person shall comply with the procedures laid down in § 12. ';
49. Point 6 of Annex 3 reads as follows:
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Regulation Information
| Citation | Government Decree No. 245 / 2009 Coll., amending Government Decree No. 336 / 2004 Coll., laying down technical requirements for medical devices and amending Government Decree No. 251 / 2003 Coll., amending certain Government Regulations issued for the implementation of Act No. 22 / 1997 Coll., on Technical Requirements for Products and amending and supplementing certain laws, as amended, as amended by Government Decree No. 212 / 2007 Coll. |
|---|---|
| Regulation Type | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 05.08.2009 |
|---|---|
| Effective from | 21.03.2010 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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