Government Decree No. 307 / 2009 Coll.
Government Regulation amending Government Decree No. 154 / 2004 Coll., laying down technical requirements for active implantable 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
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04.09.2009
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307
GOVERNMENT REGULATION
of 27 July 2009
amending Government Regulation No 154 / 2004 Coll., laying down technical requirements for active implantable 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
The Government orders pursuant to Article 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., (hereinafter referred to as "the Act") to implement § 2 (b), (c) and (d), § 3 (2), § 11 (1) and (2), § 11a (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 and Act No. 58 / 2005 Coll. (hereinafter referred to as "the Act on Medical Devices"):
Government Decree No. 154 / 2004 Coll., laying down technical requirements for active implantable 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, is amended as follows:
1. Paragraph 1, including footnote 1, reads as follows:
(1) This Regulation implements the relevant provisions of the European Community1) and regulates the technical requirements for active implantable medical devices ("active devices"). Medical devices are active in accordance with § 2 (2) (f) of the Medical Devices Act, including all accessories under § 2 (3) of the Medical Devices Act. Active devices may also be manufactured with an integrated medicine or human blood derivative pursuant to § 2 (2) (b) or (g) of the Medical Devices Act, and as custom medical devices or medical devices intended for clinical trials under § 2 (2) (d) or (e) of the Medical Devices Act.
(2) This Regulation shall apply to active medicinal products.
(3) This Regulation shall not apply to:
(a) medicinal products under the Drug Act;
(b) human blood, blood products, human blood plasma or blood cells of human origin, or devices containing, at the time of their placing on the market, such products of blood, plasma or cells, with the exception of those referred to in § 2 (2) (g) of the Medical Devices Act;
(c) transplants, tissues or cells of human origin and products containing or derived from tissues or cells of human origin, with the exception of those referred to in Section 2 (2) (g) of the Medical Devices Act;
(d) transplants, tissues or cells of animal origin, with the exception of those produced using non-living animal tissue or non-living animal tissue derived products.
1) Council Directive 90 / 385 / EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices. Council Directive 93 / 42 / EEC of 14 June 1993 concerning medical devices. Council Directive 93 / 68 / EEC of 22 July 1993 amending Directives 87 / 404 / EEC (simple pressure vessels), 88 / 378 / EEC (safety of toys), 89 / 106 / EEC (construction products), 89 / 336 / EEC (electromagnetic compatibility), 89 / 392 / EEC (machinery), 89 / 686 / EEC (personal protective equipment), 90 / 384 / EEC (non-automatic weighing instruments), 90 / 385 / EEC (active implantable medical devices), 90 / 396 / EEC (appliances of gaseous fuels), 91 / 263 / EEC (telecommunications terminal equipment), 92 / 42 / EEC (new temperature water boilers for liquid or gaseous fuels) and 73 / 23 / EEC (electrical equipment intended for use in certain voltage limits). 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 concerning medical devices and Directive 98 / 8 / EC concerning the placing of biocidal products on the market. ';
2. Paragraph 4, including the title and footnote 7, reads:
General principles
(1) Before placing on the market an active device must comply with the requirements set out in Annex 1 to this Regulation (hereinafter referred to as "essential requirements") and other requirements laid down in this Regulation which apply to that device taking into account the intended purpose of use. An active device which is also machinery under a government regulation setting out technical requirements for machinery shall comply with the essential health and safety requirements laid down in that Regulation to the extent that those essential requirements are more stringent than those laid down in Annex 1 to this Regulation.
(2) If the active substance complies with the relevant provisions
(a) harmonised European standards to which a reference is published in the Official Journal of the European Union;
(b) harmonised Czech technical standards transposing the standard referred to in (a); or
(c) foreign technical standards in a Member State of the European Union transposing the standard referred to in (a);
which relate to the relevant essential requirement, it shall be considered that this essential requirement is met taking into account the intended purpose of use. This does not apply if the reference from the Official Journal of the European Union has been withdrawn.
(3) For the purposes of this Regulation, the European Pharmacopoeia monograph, in particular the interaction between medicinal products and materials used in active products containing those medicinal products, shall also be considered a harmonised technical standard referred to in paragraph 2, provided that the reference to that monograph has been published in the Official Journal of the European Union. This does not apply if the reference to the monograph has been withdrawn from this Journal.
(4) Where harmonised standards do not fully cover the essential requirements referred to in paragraph 2, the Office for Technical Standardisation, Metrology and State Testing (hereinafter referred to as "the Office ') shall proceed under the law (4).
(5) Active devices using nuclear energy or sources of ionising radiation must be assessed for radiation protection by a person with appropriate accreditation (5) for this activity and authorised under specific legislation6).
(6) In assessing the active substance in terms of its electromagnetic compatibility, the Government Regulation on Technical Requirements for Products in terms of their electromagnetic compatibility shall not apply.
(7) Where an active device is intended for the administration of a medicinal product under a special legislative provision (7), it shall be covered by the Law on medical devices and by this Regulation, without prejudice to the provisions of the special legislation7), with regard to the medicinal product.
7) Act No. 378 / 2007 Coll., on Medicines and on Changes to Certain Related Acts (Law on Medicines), as amended. '
footnote 3 is deleted, including references to this footnote.
3. Paragraph 5 (1) reads as follows:
"(1) The manufacturer shall affix an active device which is neither custom-made nor intended for clinical trials, before being placed on the market or put into service, the CE8 mark) if, after the assessment of conformity with the essential requirements (" conformity assessment ') referred to in Article 10, it has been found to comply with the intended purpose of use.';
4. Paragraph 6 (1) reads as follows:
"(1) Active devices may only be placed on the market or put into service after compliance with the requirements of the Act, the Law on Medical Devices and this Regulation, provided that they are properly supplied, properly implanted or installed, maintained and used in accordance with their intended purpose of use. ';
5. Paragraph 6 (3) reads as follows:
"(3) In the Czech Republic
(a) may be placed on the market or put into service:
1. active devices bearing the CE marking; that indication indicates that the conformity of active means has been assessed in accordance with Article 10 of this Regulation; or
2. custom-made active devices if they comply with the conditions laid down in Annex 6 to this Regulation and are accompanied by a declaration under that Annex made available to a particular patient,
(b) active devices intended for clinical trials shall be made available to specialist doctors if they comply with the conditions laid down in Section 14 and Annex 6 to this Regulation.
The CE marking shall not be affixed to custom active devices and active devices intended for clinical trials. ';
6. In Article 6, paragraphs 5 to 8 are added, including footnote 11a:
"(5) Where a manufacturer intending to place an active device on the market under his own name does not have its registered office, if he or she is a legal person, permanent residence or place of business, if any, in any of the Member States of the European Communities, in order to place such active devices on the market an authorised representative; he is his only authorised representative within the European Communities.
(6) The manufacturer or authorised representative who places the active devices on the market shall, prior to being placed on the market, communicate to the Ministry, by means of the form provided for in this Regulation, the name, surname and address of the permanent residence, if any, if any, if any, of the natural person, or the name, registered office and address of the establishment, if applicable, and a description of the active means concerned.
(7) The Ministry may request to be informed of all data enabling the identification of active devices together with the labelling and instructions for use, if these active medical devices are put into service in the Czech Republic.
(8) The Ministry shall, upon request, communicate to the other Member States and to the Commission the information referred to in paragraphs 6 and 7.
11a) § 3 (l) of Act No. 123 / 2000 Coll. '.
7.
Placing on the market and putting into service after exposure
Active devices which do not comply with the requirements of this Regulation may be displayed but must be visibly marked in such a way that this fact is sufficiently obvious; such devices may be placed on the market or put into service only if the manufacturer or authorised representative places them in such a condition that they comply with the requirements laid down in this Regulation. ';
8.
Where, by way of derogation from Article 10 of this Regulation, conformity with an active device or with a group of active devices should be assessed by using only one of the procedures chosen between the procedures referred to in Article 10, or it is necessary to decide whether a particular product or group of products falls within one of the definitions laid down in Article 2 of the Medical Devices Act, the Ministry shall request the Commission to comment. ';
9. Paragraph 12 (4) reads as follows:
"(4) Certificates of the notified person in accordance with Annexes 2, 3 and 5 to this Regulation shall be valid for a maximum period of 5 years; The validity of such certificates may be extended for a further period of 5 years, at the request of the manufacturer or authorised representative, at the time specified in the contract between him and the notified person. ';
10. in Article 14 (2) (b):
"(b) with the agreement of the Ministry, even before the 60-day deadline, if the Ethics Committee concerned has given its consent to the programme of these tests, including a review of the clinical trial plan.";
11. in Article 14, the following paragraphs 3 and 4 are added:
"(3) The manufacturer or his authorised representative shall notify the Ministry of the completion of the clinical trial, including its justification, in the event of its 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. The manufacturer or his authorised representative shall keep the report referred to in point 2.3.7 of Annex 7 to this Regulation and submit it to the inspection authorities upon request.
(4) Clinical trials shall be carried out in accordance with Annex 7 to this Regulation. "
12. In Article 15, paragraphs 3 to 5 are added:
"(3) The notified person shall inform the Authority and the Ministry of all certificates issued, modified, supplemented, suspended and withdrawn, as well as of the refusal to issue the certificate, and shall inform the other notified persons within the scope of this Regulation of the certificates suspended and withdrawn, as well as of the refusal to issue the certificate and shall inform them on request of the certificates issued. The notified person shall also make available on request all information on certificates issued.
(4) Where the notified person finds that the relevant requirements of this Regulation have not been met or are no longer met by the manufacturer or that the certificate should not have been issued, he shall take a decision to suspend or withdraw the issued certificate or restrict the scope of its validity unless the manufacturer ensures compliance with the relevant requirements by introducing appropriate corrective measures. In the event of suspension, withdrawal or any restriction of the certificate or where action by the Office may be necessary, the notified person shall inform the Office thereof. When informing the competent authorities of other Member States and the Commission of certificates which have been suspended or withdrawn by the notified person, the law shall apply.
(5) The person nominated shall, upon request, provide the Office with all relevant information and documents, including budgetary documents, enabling verification of compliance with the criteria set out in Annex 8 to this Regulation. ';
13. In Annex 1, point 5a is added:
"5a. The demonstration of compliance with the essential requirements shall include a clinical evaluation as set out in Annex 7 to this Regulation. ';
14. In Annex No 1, at the end of point 9.7, the sentence "For active devices containing software or which are in themselves software, software shall be validated according to the latest knowledge, taking into account the principles of life cycle development, risk management, validation and verification. ';
15. In Annex No 1, points 10.1 to 10.5, including footnote 20, read:
"10.1. If an active substance contains, as an integral part of it, a substance which, when used alone, can be considered as a medicinal product under the Drug Act and which can act as an additional effect on the body to the effect of the active substance, the quality, safety and usefulness of that substance shall be verified by analogy using the methods set out in the Drug Act.
10.2. For the substances referred to in the preceding paragraph, the notified person, after verifying the usefulness of the substance as part of an active device and taking into account the intended purpose of the use of the active substance, shall request a technical opinion on the quality and safety of the substance, including a clinically verified risk for the inclusion of the substance in the active substance, from one of the competent authorities of the Member States of the European Communities or from the European Medicines Agency (EMEA). Where an opinion is given by the Institute, it shall take into account the production processes and data on the usefulness of the inclusion of the substance in the active substance, as indicated by the notified person.
10.3. Where an active device contains, as an integral part of, a human blood derivative, a notified person, after verifying the usefulness of that human blood derivative as part of an active device and taking into account the intended purpose of the active device, shall require the EMEA's expert opinion on the quality and safety of that human blood derivative, including the clinically verified risk of the incorporation of the human blood derivative into the active device.
10.4. Where changes are made to a substance or a human blood derivative incorporated into an active substance under the previous paragraphs, in particular as regards their manufacturing processes, the notified person shall be informed of the changes and shall request a technical opinion for medicinal products or human blood derivatives from the Authority which issued the original expert opinion to confirm that the quality and safety of the use of that substance or human blood derivative is maintained. If the initial professional opinion was issued by the Institute, the Institute shall take into account data on the usefulness of the incorporation of a substance or a derivative from human blood into an active medium, as indicated by the notified person, in order to ensure that changes have no negative impact on the identified risk when integrating a substance or derivative from human blood into an active medium.
10.5. Where an institution which has issued an initial expert opinion receives information on a substance or a human blood derivative that could affect a specified risk when integrating a substance or derivative into an active medium, it shall communicate its opinion to the notified person whether or not that information gives rise to an impact on a specified risk for the inclusion of a substance or derivative in an active medium. The notified person shall take into account the updated expert opinion when reassessing his conclusion from the conformity assessment procedure.
20) Act No. 378 / 2007 Coll., on Medicines and Changes to Certain Related Acts (Law on Medicines). '
16. in Annex 1, point 14.2.1 shall read:
"14.2.1. the name and address of the manufacturer and the name and address of the authorised representative, unless the manufacturer has its registered office in a Member State, ';
17. In Annex 1, point 14.2.10 is replaced by the following:
"14.2.11. indication that the active substance contains a human blood derivative within the meaning of Article 4 (9) of this Regulation. ';
18. In Annex 1, point 15.10.4 is replaced by the following:
"15.10.5. Date of issue or last revision of the instructions. ';
19. in Annex 2, point 2.2 shall read:
"2.2. draw up a written declaration of conformity which it is obliged to keep. This declaration shall be drawn up for one or more active devices accurately identified by the name of the active device, the active device code or any other unique reference. ';
20. in Annex 2, point 3.1.5 reads:
"3.1.5. a commitment by the manufacturer to implement and update the systematic process of obtaining and evaluating the information and experience of users acquired with active devices placed on the market (hereinafter referred to as" after-sales supervision "), including the provisions set out in Annex 7 to this Regulation. Part of this commitment is the obligation of the manufacturer to notify the institute of the undesirable incident (15) as soon as it becomes aware of them. '
21. In Annex No 2, point 3.2, the sentence "This shall include, in particular, the relevant documentation, data and records arising from the procedures referred to in point 3.2.3 shall be added at the end of the second paragraph."
22. 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 active devices or parts thereof are carried out by a third party, methods for monitoring the effective functioning of the quality system, and in particular the manner and extent of control carried out over the third party, ';
23. in Annex 2, the following points 3.2.3.3 to 3.2.3.5 are inserted after point 3.2.3.2:
"3.2.3.3. a statement as to whether the active substance contains, as an integral part of, the substance or human blood derivative referred to in point 10 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 use of the active substance;
3.2.3.4. preclinical evaluation,
3.2.3.5. clinical trial as set out in Annex 7 to this Regulation; ';
24. In Annex 2, point 3.3, the fourth sentence is replaced by the following: "The assessment shall include an inspection visit at the manufacturer's premises and, where appropriate, a check of production processes at the manufacturer's suppliers' or contractors' premises. '
25. in Annex 2, point 4.2.1. read:
"4.2.1. the design, manufacture and performance of the active device concerned and shall include the documents necessary to assess whether the active device complies with the requirements of this Regulation, and in particular points 3.2.3. and 3.2.4. of this Annex, ';
26. in Annex 2, point 4.2.5:
"4.2.5. Clinical trial as referred to in Annex 7 to this Regulation, ';
27. in Annex 2, point 4.3 reads:
"4.3. Scope of the notified person
4.3.1. The notified person shall examine the application and, if the active substance 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 compliance of the active substance with the requirements of this Regulation. The EC design review certificate shall contain the conclusions of the examination, the conditions of validity of the certificate, the data needed to identify the approved active device design, and, where appropriate, a description of the intended use of the active device.
4.3.2. In the case of active devices referred to in point 10.2. of Annex 1 to this Regulation, the notified person shall, in accordance with point 10.2. of Annex 1 to this Regulation, request one of the competent authorities of the Member States of the European Communities, the Czech Republic, or the EMEA before taking a decision on a professional opinion. 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 expert opinion of the competent authority of the Member State of the European Communities or the EMEA shall be included in the dossier for the active substance. When taking decisions, the person nominated shall pay due attention to the expert opinion and shall communicate his final decision to the competent authority or the EMEA which issued the expert opinion.
4.3.3. In the case of active devices referred to in point 10.3 of Annex 1 to this Regulation, the EMEA 's expert opinion shall be included in the dossier concerning the active 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.'.
28. 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, preclinical and clinical trials, the post-marketing or entry-into-service clinical follow-up plan and, where appropriate, the results of subsequent clinical monitoring and any other results, ';
29. in Annex 2, point 6.1 shall read:
"6.1. For a period of at least 15 years from the date of manufacture of the last active device, the manufacturer or his authorised representative shall keep at the disposal of the competent public authorities:
6.1.1. a written declaration of conformity,
6.1.2. The quality system documentation referred to in point 3.1.2 of this Annex, and in particular the documentation, data and records referred to in point 3.2.3. of this Annex,
6.1.3. Documentation of amendments according to paragraph 3.4 of this Annex,
6.1.4. Documentation according to paragraph 4.2 of this annex,
6.1.5. certificates and other documents of the notified person referred to in points 3.4, 4.3 and 5.3 of this Annex. ';
30. In Annex No 2, point 6.3 is deleted.
31. In Annex 2, point 7 is added:
'7. Use for active devices referred to in § 2 (2) (g) of the Medical Devices Act.
Upon completion of the manufacture of each batch of active devices referred to in § 2 (2) (g) of the Medical Devices Act, the manufacturer shall inform the notified person of the release of a batch of such active devices and send him a certificate concerning the release of a batch of human blood derivative used in this active device, issued by the competent laboratory designated for that purpose by the Member State, in the Czech Republic in accordance with the specific legislature20). '
32. in Annex 3, point 3.1 shall read:
"3.1. a general description of the type, including all planned variants, and its intended uses, ';
33. In Annex 3, points 3.5 to 3.9. read:
"3.5. Results of design calculations carried out, risk analysis, research, technical tests and other possible results;
3.6. a statement as to whether the active substance contains, as an integral part of the substance or human blood derivative referred to in point 10 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 active substance;
3.7. preclinical evaluation,
3.8. The clinical trial referred to in Annex 7 to this Regulation,
3.9. draft package leaflet. '
34. 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 is 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 the manufacturer's place of residence and place of business, if the manufacturer is a natural person living abroad, the name and, where applicable, the surname of the manufacturer, 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 active devices referred to in point 10.2. of Annex 1 to this Regulation, the notified person shall, in accordance with point 10.2. of Annex 1 to this Regulation, request one of the competent authorities of the Member States of the European Communities, the Czech Republic, or the EMEA before taking a decision on a professional opinion. 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 expert opinion of the competent authority of the Member State of the European Communities or the EMEA shall be included in the dossier for the active substance. When taking decisions, the person nominated shall pay due attention to the expert opinion and shall communicate his final decision to the competent authority or the EMEA which issued the expert opinion.
5.3. In the case of active devices referred to in point 10.3 of Annex 1 to this Regulation, the EMEA 's expert opinion shall be included in the dossier concerning the active 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.'.
35. In Annex 3, point 7.3., the words "a copy of the EC-type examination certificate and its additions for at least 5 years after the last active device has been manufactured 'are replaced by the words" a copy of the EC-type examination certificates and their additions for at least 15 years after the last active device has been manufactured,';
36. In Annex 3, point 7.4 is deleted.
37. In Annex 4, point 1, "Verification 'is replaced by" EC verification'.
38. In Annex 4, point 4 reads as follows:
"4. The manufacturer shall provide a guarantee that he or she will establish and update a systematic procedure to obtain and evaluate the information and experience of users with the active means he has placed on the market and, following that activity, to implement the appropriate measures (after-sales supervision) including the provisions contained in Annex 7 to this Regulation. Furthermore, the manufacturer undertakes to notify the Institute of adverse events as soon as it becomes aware of them. ';
39. in Annex 4, point 6.3 reads:
"6.3. Statistical verification of medical devices by comparison or measurement uses acceptance plans with operational characteristics which ensure a high level of safety and performance according to the latest knowledge of science and technology. The adoption plans shall be established in accordance with the harmonised standards referred to in Article 4 (2), taking into account the nature of the groups of medical devices concerned. ';
40. In Annex 4, point 7 is added:
'7. Use for active devices referred to in § 2 (2) (g) of the Medical Devices Act.
On completion of the production of each batch of active devices referred to in § 2 (2) (g) of the Medical Devices Act, the manufacturer shall inform the notified person of the release of the batch of those active devices and send him a certificate concerning the release of the batch of a human blood derivative used in this active device, issued by the competent laboratory designated for that purpose by the Member State, in the Czech Republic in accordance with the specific legislation20). '
41. in Annex 5, point 2 shall read:
"2. The EC declaration of conformity to type shall be part of the procedure whereby the manufacturer fulfilling the obligations referred to in point 1 of this Annex guarantees and declares that the relevant active means conform to the type described in the EC type-examination certificate and comply with the provisions of this Regulation which apply to them.
Manufacturer or authorised representative
2.1 bears the CE marking provided for in Section 5, to which the identification number of the notified person is attached; and
2.2. Draws a written declaration of conformity which it is obliged to keep. This declaration shall be drawn up for one or more active devices produced, shown to be the name of the active device, the active device code or any other unique reference. ';
42. In Annex 5, point 3.1.6 reads:
"3.1.6. the manufacturer's commitment to implement and update the systematic procedure for evaluating the experience gained from active devices placed on the market (after-sales supervision), including the provisions set out in Annex 7 to this Regulation. Part of this commitment is the obligation of the manufacturer to notify the institute of the undesirable incident (15) as soon as it becomes aware of them. '
43.In Annex 5, point 3.2.2.2 is inserted after point 3.2.2.3.
"3.2.2.3. Where the production or output control and testing of active devices or parts thereof is carried out by a third party, methods of monitoring the effective functioning of the quality system, and in particular the method and extent of control carried out over the third party, ';
44. In Annex 5, the following point 4.4.2 is inserted after point 4.2.1.:
"4.2.2. technical documentation, ';
Point 4.2.2. is renumbered point 4.2.3.
45. In Annex 5, point 6 is added:
'6. Application to active devices referred to in § 2 (2) (g) of the Medical Devices Act.
On completion of the production of each batch of active devices referred to in § 2 (2) (g) of the Medical Devices Act, the manufacturer shall inform the notified person of the release of the batch of those active devices and send him a certificate concerning the release of the batch of a human blood derivative used in this active device, issued by the competent laboratory designated for that purpose by the Member State, in the Czech Republic in accordance with the specific legislation20). '
46. Point 2.1 of Annex 6, including footnote 22a, reads as follows:
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Regulation Information
| Citation | Government Decree No. 307 / 2009 Coll., amending Government Decree No. 154 / 2004 Coll., laying down technical requirements for active implantable 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 |
|---|---|
| Regulation Type | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 04.09.2009 |
|---|---|
| Effective from | 21.03.2010 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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