Government Regulation No. 65 / 2011 Coll.
Government Regulation 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
Valid
Effective from 01.04.2011
65
GOVERNMENT REGULATION
of 23 February 2011
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
The Government mandates, pursuant to Article 22 of Act No. 22 / 1997 Coll., on the technical requirements for products and on the modification 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 § 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., Act No. 58 / 2005 Coll., Act No. 227 / 2009 Coll., and Act No. 196 / 2010 Coll. (hereinafter referred to as "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 laws, as amended, as amended, as amended by Government Decree No. 212 / 2007 Coll. and Government Decree No. 245 / 2009 Coll., is amended as follows:
1. in Section 1 of the Introductory Part of the Provisions, Section 5 (2) and Annex 12, points 1.2.7.1, 1.2.8.5 and 1.2.10, the words "European Communities" are replaced by the words "European Union."
2. In Paragraph 4 (1), the second sentence is replaced by the following: "Where there is an appropriate risk, medical devices which are simultaneously machinery (8a) must 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 laid down in Annex 1 to this Regulation. ';
3. in Articles 4 (6) and 7 (2) (e), the words "the Commission of the European Communities" shall be replaced by the words "the European Commission."
4. Paragraph 6 (3) reads as follows:
"(3) 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 inform the Ministry of Industry and Trade of the measures referred to in paragraphs 1 and 2. ';
5. In Paragraph 9 (5), the words "(hereinafter referred to as the Institute) 'are replaced by the words" (hereinafter referred to as the Institute)'.
6. in Sections 10 (5), 12 (6) and (7), 16 (8), Annex 1 (7.4.2), Annex 2 (8), Annex 4 (9), Annex 5 (7), Annex 10 (2.3.5) and Annex 12 (1.2.7.3), the words "European Communities" shall be deleted;
7. In Article 11 (5), "paragraphs 1 to 4 'is replaced by" paragraphs 2 and 4'.
8. Sections 13 and 14, including the headings, read:
Notification obligations
(1) A manufacturer who, in accordance with the procedures referred to in Article 4 (3), places medical devices on the market or put into service, an authorised representative or a person involved in the activities referred to in Article 11 shall notify the Ministry in electronic form:
(a) start-up in accordance with Annex 13 to this Regulation;
(b) the cessation of activities in accordance with Annex 13 to this Regulation;
(c) placing a medical device on the market in accordance with Annex 15 to this Regulation before the medical device is placed on the market;
(d) the placing on the market of a medical device in accordance with Annex 15 to this Regulation; and
(e) an amendment to any of the data notified under (a) and (c).
The data referred to in Annex 15 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 13 to this Regulation. The manufacturer of a custom medical device shall notify the Ministry in electronic form only of the data referred to in points (a) and (b) and of any change to any of the data notified under point (a).
(2) A person placing a medical device on the market or putting it into service within the territory of the Czech Republic is required, at the request of the Ministry, to provide information enabling the medical device to be identified and supporting documents used to assess conformity.
(3) If a manufacturer intending to place on the market, under his name, a medical device referred to in paragraph 1 or 2, does not have its head office in a Member State, he shall entrust to the marketing of such medical devices an authorised representative who is his only authorised representative within the Member States.
(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 serving medical devices shall notify the Ministry in electronic form
(a) start-up in accordance with Annex 14 to this Regulation;
(b) the cessation of activities in accordance with Annex No 14 to this Regulation; and
(c) an amendment to any of the data notified under (a).
Data set
(1) Data
(a) the medical devices and persons referred to in Section 13;
(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 7 to this Regulation;
(c) obtained in accordance with the procedure governing notification and registration of adverse events (21); and
(d) clinical trials
they shall be processed in accordance with this Regulation in the information system provided for in Section 41 of the Medical Devices Act until the person handling the medical devices has notified the Ministry of Termination and for an additional 20 years. Data from the information system are accessible to the Ministry, the Office for Technical Standardisation, Metrology and State Testing (hereinafter referred to as the Office), the Institute, the State Office for Nuclear Safety for Ionizing Radiation Sources, the Institute of Health Information and Statistics of the Czech Republic and the Czech Trade Inspection. Data from the information system on adverse events (22) and clinical trials of medical devices are accessible only to the Ministry, Institute and Institute of Health Information and Statistics of the Czech Republic and to the State Office of Nuclear Safety for sources of ionising radiation.
(2) The information referred to in paragraph 1 (a) and (d) shall be made available in electronic form in accordance with Annexes 13 to 16 to this Regulation. "
9. Paragraph 15 (1) reads as follows:
"(1) For medical devices intended for clinical examinations, the manufacturer, the authorised representative or the contracting entity shall proceed in accordance with Annex 8 to this Regulation and shall notify the Institute of its intention to carry out the clinical trials in the form set out in Annex 16 to this Regulation and shall at the same time submit a declaration including the documentation referred to in point 2.2 of Annex 8 to this Regulation. ';
10. In Paragraph 15 (2), "Ministry 'is replaced by" Institute'.
11. in Article 15 (2) and (5), "Ministry" is replaced by "Constitution."
12.Paragraph 15 (6) reads as follows:
"(6) The manufacturer, authorised representative or contracting entity shall notify the Institute of the end of the clinical trial, including its justification in the event of 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 authorised representative shall keep the report referred to in Article 11 (c) of the Medical Devices Act available to the competent authorities. ';
13. in Article 16 (5), the words "and the Ministry" shall be deleted;
14. In Article 16 (6), the words "Member States' and the words" Commission of the European Communities' shall be replaced by the words "European Commission ';
15. in Annex 1, point 7.1.2 shall read:
"7.1.2. Mutual compatibility between the materials used and biological tissues, cells and body fluids, taking into account the intended purpose of use, ';
16. in Annex 1, points 7.4.2 and 7.4.5, the word "Institute" is replaced by "Institute."
17. in Annex 1, point 7.4.4 reads:
"7.4.4. Where changes are made to the complementary substance incorporated into the medical device, in particular as regards its manufacturing process, the notified person shall be informed of the changes, who shall request the expert opinion of the competent authority of the medicinal products (i.e. the authority which issued the original professional opinion) in order 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 incorporation of the additional substance into the medical device, as indicated by the notified person, in order to ensure that the changes have no negative impact on the risk identified when the additional substance is incorporated into the medical device. ';
18. In Annex 1, the following point 12.1a. is inserted after point 12.1.:
"12.1a. In the case of medical devices which contain software or which are itself medical software, the software shall be validated according to the latest knowledge, taking into account the principles of life cycle development, risk management, validation and verification. ';
19. In Annex 1, point 12.9, the words "where appropriate 'are replaced by the words" where appropriate'.
20. in Annex 1, point 13.3.1 reads:
"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 Union, provided that they are distributed within the European Union, the label or label, outer packaging or instructions for use shall in addition include the name and, where applicable, the name and surname or business name or business name and the address of the authorised representative's place of business or registered office if the manufacturer does not have his registered office in the Member State; ';
21. in Annex 1, point 13.3.6. read:
"13.3.6. where appropriate, indication that it is a disposable medical device. The manufacturer's information that it is a disposable medical device must be uniform within the European Union, '.
22. in Annex 1, point 13.6.8, the words "for 1 use" are replaced by the words "for single use."
23. In Annex 1, point 13.6.17, the word "or 'shall be inserted after the word" issue'.
24. in Annex 2, point 3.1.7, Annex 4, point 3, Annex 5, point 3.1.1.8, Annex 7, point 4 and Annex 8, point 5, the word "Institute" shall be replaced by "Constitution."
25. in Annex 2, point 4.3.2 reads:
"4.3.2. In the case of medical devices referred to in point 7.4.1 of Annex 1 to this Regulation, the notified person shall, in accordance with point 7.4.2 of Annex 1 to this Regulation, request one of the competent authorities of the Member States, the Czech Republic, the Institute, 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 receipt of the complete dossier. The expert opinion of the competent authority of a Member State or the EMEA should be included in the medical device dossier. 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. ';
26. In Annex No 2, point 6.2 is deleted.
27. in Annex 3, point 3.6. and Annex 8, point 3.2.5, the word "use" shall be inserted after the word "purpose."
28. In Annex 3, point 5.2 is replaced by the following:
"5.2. In the case of medical devices referred to in point 7.4.1 of Annex 1 to this Regulation, the notified person shall, in accordance with point 7.4.2 of Annex 1 to this Regulation, request one of the competent authorities of the Member States, the Czech Republic, the Institute, 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 receipt of the complete dossier. The expert opinion of the competent authority of a Member State or the EMEA should be included in the medical device dossier. 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. ';
29. in Annex 8, point 2.2.9.:
"2.2.9. the name of the legal person or the name or, where applicable, the name and surname of the natural person who has commissioned the clinical trial and, where applicable, the name and surname of the doctor or other authorised person who has practically carried out the clinical trial; the persons are subject to the obligations and responsibilities set out in Sections 8 to 14 of the Law on Medical Devices, '.
30. In Annex 9, point 1.4:
"1.4." Active medical device "means a medical device whose activity depends on a source of electrical or other energy which is not directly produced by the human body or gravity and which acts through the conversion of that energy; medical devices intended to transmit energy or substances between an active medical device and a patient without any significant change shall not be considered an active medical device; separate software shall be considered an active medical device; ';
31. in Annex 10, point 1.3, the word "regular" is replaced by the word "full."
32. In Annex 10, point 1.6, the words "in accordance with the provisions of Section 49 of the Law on Medical Devices' shall be inserted after the words" considered '.
33. In Annex 10, point 2.3.5, "adverse events' is replaced by" adverse events'.
34. In Annex No 10, point 3, "§ 12 (1) (e) and § 12 (2) (c) 'is replaced by" § 11 (c)';
35. Annexes No 13 to 16 shall read as follows:
"Annex No 13 to Government Decree No 336 / 2004 Coll.
1.
Form for notification of the person handling the medical devices referred to in § 13 (1) of Decree No. 336 / 2004 Coll., as amended by Decree No. 65 / 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. 14
Annex No 14 to Decree No 336 / 2004 Coll.
1.
Form for notification of the person handling the medical devices referred to in § 13 (5) of Decree No. 336 / 2004 Coll., as amended by Decree No. 65 / 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. 15
Annex No 15 to Decree No 336 / 2004 Coll.
1.
Form for notification of a 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.
Příloha č. 16
Annex No. 16 to Government Decree No. 336 / 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. 65 / 2011 Coll., 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 |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 18.03.2011 |
|---|---|
| Effective from | 01.04.2011 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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