Government Decree No. 66 / 2011 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, as amended by Government Decree No. 307 / 2009 Coll.
Valid
Effective from 01.04.2011
66
GOVERNMENT REGULATION
of 23 February 2011
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, as amended by Government Regulation No 307 / 2009 Coll.
The Government hereby orders, pursuant to Article 22 of Act No. 22 / 1997 Coll., on the 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 No. 123 / 2000 Coll., on medical devices and amending certain related laws, as amended by Act No. 130 / 2003 Coll., Act No. 274 / 2003 Coll., Act No. 58 / 2005 Coll., Act No. 227 / 2009 Coll., and Act No. 196 / 2010 Coll. (hereinafter" the Act on Medical Devils'):
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, as amended by Government Regulation No 307 / 2009 Coll., is amended as follows:
1. in Articles 1 (1) and 13 (2), the words "the European Communities" shall be replaced by the words "the European Union."
2. In Paragraph 4 (1), the second sentence is replaced by the sentence "If there is an appropriate risk, then an active device, which is also machinery under a government regulation setting out technical requirements for machinery, must also comply with the essential health and safety requirements laid down in that regulation of the Government to the extent that those essential requirements are more specific than those set out in Annex 1 to this Regulation. '
3. Paragraph 5 (7) reads as follows:
"(7) The European Commission and the competent authorities of the Member States of the European Union or of the European Free Trade Association, which is a Contracting Party to the European Economic Area, hereinafter referred to as" the Member State, "shall be informed by the Ministry of Industry and Trade. 11 '.
4. In Article 6, paragraphs 5 to 8 are deleted.
5. footnote 11a is deleted;
6. in Article 8 (2) (a) and (b), the words "Commission of the European Communities" shall be replaced by the words "European Commission."
7. In Paragraph 9 (2), the words "(hereinafter referred to as" the ninjisterstvo ')' are replaced by the words "(hereinafter referred to as" the Ministry ')' and the words "(hereinafter referred to as" the Institute ')' are replaced by the words "(hereinafter referred to as" the Institute ').
8. In Article 10 (5), the words "the European Communities' are deleted.
9. In Article 11, the word "Commission 'is replaced by" European Commission';
10. in Article 12 (5), the words "the Commission of the European Communities" shall be replaced by the words "the European Commission";
11.
Clinical trials
(1) For active devices intended for clinical trials by the manufacturer, authorised representative or contracting entity, the Institute shall notify the intention to carry out clinical trials in the form set out in Annex 12 to this Regulation at the same time as it shall submit a declaration including the documentation referred to in point 2.2 of Annex 6 to this Regulation.
(2) Clinical trials of the active substance may be initiated by the manufacturer
(a) after 60 days from the date of notification referred to in paragraph 1, unless the Institute gives a negative opinion to the manufacturer, the authorised representative or the contracting entity within that period on the performance of those tests for the purpose of protecting the health of the body of evaluation, protection of public health or other public interest; or
(b) the positive opinion of the Constitution, even before the expiry of 60 days from the date of notification referred to in paragraph 1.
(3) The manufacturer or his authorised representative shall notify the Institute of Termination of the Clinical Test, including its justification, in the event of its early termination. If the clinical trial is terminated prematurely for safety reasons, the Institute shall forward this notification to all Member States and to the European Commission. The manufacturer or his authorised representative shall keep the report referred to in Article 11 (1). (c) the law on medical devices 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 (3), the words "and the Ministry" shall be deleted;
13. in Article 15 (4), the word 'Commission' is replaced by 'European Commission';
14.
Notification obligations
(1) A manufacturer who, in accordance with the procedures referred to in Article 6 (3), places active devices on the market or enters into service or notifies the Ministry in electronic form
(a) start-up in accordance with Annex 9 to this Regulation;
(b) the cessation of activities in accordance with Annex 9 to this Regulation;
(c) placing an active device on the market in accordance with Annex 11 to this Regulation before the active device is placed on the market;
(d) the cessation of the placing on the market of an active substance in accordance with Annex 11 to this Regulation; and
(e) an amendment to any of the data notified under (a) and (c).
The data referred to in Annex 11 to this Regulation shall be notified only after the notifier has received a registration number from the Ministry on the basis of compliance with the notification requirement in accordance with Annex 9 to this Regulation.
(2) The person placing a medical device on the market or putting it into service on the territory of the Czech Republic is required to provide, at the request of the Ministry, information enabling the active device to be identified and supporting documents used to assess conformity.
(3) Where a manufacturer intending to place active devices on the market under his name as referred to in paragraph 1 or 2 is not established in a Member State, he shall entrust an authorised representative who is his only authorised representative within the Member States to the marketing of those active devices.
(4) Upon request, the Ministry shall communicate to the Member State and the European Commission the information resulting from paragraphs 1 to 3 provided by the manufacturer or his authorised representative.
(5) The distributor, importer and person performing the service of the active means are notified to the Ministry in electronic form
(a) start-up in accordance with Annex 10 to this Regulation;
(b) the cessation of activities in accordance with Annex 10 to this Regulation; and
(c) an amendment to one of the particulars notified under (a). ';
15. After Paragraph 16, the following Section 16a is inserted:
Data set
(1) Data
(a) persons and active means referred to in Section 16;
(b) the certificates issued, modified, suspended and cancelled, as well as the refusal of applications for certification in accordance with the procedures laid down in Annexes 2 to 5 to this Regulation;
(c) obtained in accordance with the procedure governing the notification and registration of adverse events (15); and
(d) clinical trials
are processed in accordance with this Regulation in an information system pursuant to Section 41 of the Medical Devices Act until the person handling the active means has notified the Ministry of Discontinuation and for a further 20 years. Data from the information system are accessible to the Ministry, the Office, the Institute, the State Office for Nuclear Safety for sources of ionizing radiation, the Institute of Health Information and Statistics of the Czech Republic and the Czech Trade Inspection. Data from the information system on adverse events 13) and clinical trials of active devices are accessible only to the Ministry, Institute and Institute of Health Information and Statistics of the Czech Republic.
(2) The information referred to in paragraph 1 (a) and (d) shall be made available in electronic form in accordance with Annexes 9 to 12 to this Regulation. ';
16. In Annex 1, point 10.2., the words "European Communities' are deleted.
17. in Annex 1, points 10.2, 10.4 and 10.5, the word "Institute" is replaced by "Institute."
18. In Annex 1, point 10.4, the word "Constitution 'is replaced by the word" Constitution' and the words "to be sure 'are replaced by the words" to be secured'.
19. in Annex 2, point 3.1.5., Annex 4, point 4., Annex 5, point 3.1.6. and in Annex 6, point 5, the word "Institute 'is replaced by" Institute'.
20. in Annex 2, point 4.3.2 reads:
"4.3.2. In the case of active devices referred to in point 10.2. of Annex 1 to this Regulation, the notified person, in accordance with point 10.2. of Annex 1 to this Regulation, shall, before taking a decision on a professional opinion, request one of the competent authorities of the Member States, the Czech Republic, the Institute, or the EMEA. Where a professional opinion is requested by the Institute, it shall draw up a professional opinion within 210 days of receipt of the complete dossier. The expert opinion of the competent authority of a Member State or the EMEA should be included in the dossier for the active substance. When taking decisions, the person nominated shall pay due attention to the expert opinion and communicate his final decision to the institution which issued the expert opinion. ';
21. in Annex 3, point 5.2 shall read:
"5.2. In the case of active devices referred to in point 10.2. of Annex 1 to this Regulation, the notified person, in accordance with point 10.2. of Annex 1 to this Regulation, shall, before taking a decision on a professional opinion, request one of the competent authorities of the Member States, the Czech Republic, the Institute, or the EMEA. Where a professional opinion is requested by the Institute, it shall draw up a professional opinion within 210 days of receipt of the complete dossier. The expert opinion of the competent authority of a Member State or the EMEA should be included in the dossier for the active substance. When taking decisions, the person nominated shall pay due attention to the expert opinion and communicate his final decision to the institution which issued the expert opinion. ';
22. in Annex 7, point 2.3.5, the words "adverse events" are replaced by "adverse events."
23. in Annex 7, point 2.3.7 reads as follows:
"2.3.7. The written report signed by the examiner shall contain a critical evaluation of all data collected during the clinical trial. ';
24. Point 3 of Annex 7 reads as follows:
'3. After the completion of the clinical trials, a final written report shall be drawn up in accordance with Section 11 (c) of the Medical Devices Act. ';
25. Annexes 9 to 12 shall read:
"Annex No 9 to Government Decree No 154 / 2004 Coll.
1.
Form for notification of the person handling the active means referred to in § 16 (1) of Decree No. 154 / 2004 Coll., as amended by Government Regulation No. 66 / 2011 Coll.
2.
2.1. The form in electronic form for the provision of the data referred to in point 1 and the manner in which it is completed shall be published by the Ministry of Health on its website.
2.2. The authorised representative pursuant to § 3 (l) of the Medical Devices Act also attaches an electronic copy of the authorization of the manufacturer with its registered office outside the Member States in Czech or English.
2.3. Where the person making out the form is not the same as the person making the form, that person shall also attach an electronic copy of the power of attorney proving authorisation for such an operation.
Příloha č. 10
Annex No 10 to Government Decree No 154 / 2004 Coll.
1.
Form for notification of the person handling the active means referred to in Article 16 (5) of Decree No. 154 / 2004 Coll., as amended by Government Regulation No. 66 / 2011 Coll.
2.
2.1. The form in electronic form for the provision of the data referred to in point 1 and the manner in which it is completed shall be published by the Ministry of Health on its website.
2.2. Where the person making out the form is not the same as the person making the form, that person shall also attach an electronic copy of the power of attorney proving authorisation for such an operation.
Příloha č. 11
Annex No 11 to Government Decree No 154 / 2004 Coll.
1.
Form for notification of active implantable medical device
2.
2.1. The form in electronic form for the provision of the data referred to in point 1 and the manner in which it is completed shall be published by the Ministry of Health on its website.
2.2. The form shall be accompanied by an electronic copy of the final clinical trial report, the certificate (if any) and the declaration of conformity in Czech or English.
2.3. The form is accompanied by an electronic copy of the instructions for use in the Czech language.
2.4. Where the person making out the form is not the same as the person making the form, that person shall also attach an electronic copy of the power of attorney proving authorisation for such an operation.
Annex No. 12 to Government Decree No 154 / 2004 Coll.
Form of intent to conduct clinical trials
Efficacy
This Regulation shall take effect on 1 April 2011.
Prime Minister:
RNDr. Netime v. r.
Minister for Health:
Doc. MUDr. Heger, CSc., v. r.
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Regulation Information
| Citation | Government Regulation No. 66 / 2011 Coll., 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 acts, as amended, as amended by Government Regulation No. 307 / 2009 Coll. |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 21.03.2011 |
|---|---|
| Effective from | 01.04.2011 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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