Government Decree No. 67 / 2011 Coll.
Government Regulation amending Government Regulation No. 453 / 2004 Coll., laying down technical requirements for in vitro diagnostic medical devices, as amended by Government Regulation No. 246 / 2009 Coll.
Valid
Effective from 01.04.2011
67
GOVERNMENT REGULATION
of 23 February 2011
amending Government Regulation No 453 / 2004 Coll., laying down technical requirements for in vitro diagnostic medical devices, as amended by Government Regulation No 246 / 2009 Coll.
The Government mandates pursuant to § 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., as amended by Act No. 130 / 2003 Coll., Act No. 274 / 2003 Coll. and Act No. 58 / 2005 Coll., Act No. 227 / 2009 Coll. and Act No. 196 / 2010 Coll., ("the Act on Medical Devices'):
Government Regulation No. 453 / 2004 Coll., laying down technical requirements for in vitro diagnostic medical devices, as amended by Government Regulation No. 246 / 2009 Coll., is amended as follows:
1. In Section 1 of the Introductory Part of the Provisions, Section 7 (3) and Section 9 (5), the words "European Communities' are replaced by the words" European Union '.
2. in Paragraph 3 (d):
"(d) by an authorised representative, a person established in a Member State of the European Union or a European Free Trade Association, who is at the same time a Contracting Party to the European Economic Area (hereinafter referred to as" the Member State "), who is authorised in writing by the manufacturer to act for him with the authorities and authorities in the Member States, having regard to the requirements resulting from this Regulation for manufacturers, '.
3. in Article 3 (e) and Annex 1, point 8.4.1, the words "European Communities" shall be deleted;
4. in Article 3 (i) (1) and (2), "in the Member States of the European Communities" shall be replaced by "in the Member States."
5. Article 11, including the title and footnote 18, reads as follows:
Notification obligations
(1) A manufacturer who places in vitro diagnostics on the market or put into service in accordance with the procedures laid down in Article 5, or an authorised representative notifies the Ministry of Health (hereinafter referred to as "the Ministry") in electronic form
(a) start-up in accordance with Annex 11 to this Regulation;
(b) the cessation of activities in accordance with Annex 11 to this Regulation;
(c) the placing on the market of in vitro diagnostics in accordance with Annex 13 to this Regulation before the in vitro diagnostics are placed on the market;
(d) the cessation of the placing on the market of in vitro diagnostics in accordance with Annex 13 to this Regulation; and
(e) an amendment to any of the data notified under (a) and (c).
The data referred to in Annex 13 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 11 to this Regulation.
(2) The notification referred to in paragraph 1 shall also include a new in vitro diagnostic, which shall bear the CE marking.
(3) A person placing in vitro diagnostics on the market or putting into service on the territory of the Czech Republic is required, at the request of the Ministry, to provide information enabling the identification of in vitro diagnostics in accordance with point 2 of Annex 13 to this Regulation and the supporting documents used to assess conformity.
(4) Where a manufacturer intending to place on the market, under his name, an in vitro diagnostic as referred to in paragraph 1 or 2 is not established in a Member State, he shall entrust an authorised representative to the marketing of such in vitro diagnostic.
(5) Pending the launch of the European Data Bank on Medical Devices (18), the Ministry shall notify the information referred to in paragraphs 1 to 3 to the manufacturer having his registered office in a Member State other than the Czech Republic, if he places in vitro diagnostics on the market in the Czech Republic.
(6) The distributor, importer and person performing an in vitro diagnostic service shall notify the Ministry in electronic form
(a) start-up in accordance with Annex 12 to this Regulation;
(b) the cessation of activities in accordance with Annex No 12 to this Regulation; and
(c) an amendment to any of the data notified under (a).
18) Commission Decision 2010 / 227 / EU of 19.4.2010 on the European Data Bank of Medical Devices (Eudamed). '.
6. In Paragraph 12 (3), the words "(hereinafter referred to as the Institute) 'are replaced by the words" (hereinafter referred to as the Institute)'.
7. Paragraph 13, including the title, reads:
Data set
(1) Data
(a) in vitro diagnostics and persons referred to in Section 11;
(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 3 to 7 to this Regulation; and
(c) obtained in accordance with the procedure governing the notification and registration of adverse events (21)
are processed in accordance with this Regulation in an information system under the Health Devices Act (22) until the person handling in vitro diagnostics has notified the Ministry of Discontinuation 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 undesirable incidents21) In vitro diagnostics are only accessible to the Ministry, Institute and Institute of Health Information and Statistics of the Czech Republic.
(2) The information referred to in paragraph 1 (a) shall be made available in electronic form in accordance with Annexes 11 to 13 to this Regulation. ';
8. In Paragraph 14 (1), "Institute 'is replaced by" Institute'.
9. In Paragraph 14 (3) (b), the words "the Commission of the European Communities' are replaced by the words" the European Commission '.
10. in Article 15 (3) and (4):
"(3) The notified person shall inform the other notified persons and the Office of the suspension or revocation of the certificates he has issued; inform the other notified persons and the Office, upon request, of the issue of a certificate or refusal of an application for the issue of certificates and provide further relevant information.
(4) Where the notified person finds that the requirements of this Regulation have not been met by the manufacturer or are no longer satisfied, or where the certificate should not have been issued, the notified person shall suspend or revoke the certificate issued or restrict its use, taking into account the principles of proportionality, unless the manufacturer ensures compliance with those requirements by introducing adequate corrective measures. In the event of suspension, restriction or revocation of the certificate or where action by the Office may be necessary, the notified person shall inform the Office thereof. ';
11. In Annex 3, point 5, "Institute 'is replaced by" Institute'.
12. Annexes No 11 to 13 shall read as follows:
"Annex No 11 to Government Decree No. 453 / 2004 Coll.
1.
Form for notification of a person handling in vitro diagnostics referred to in § 11 (1) of Government Decree No. 453 / 2004 Coll., as amended by Government Decree No. 67 / 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. 12
Annex No. 12 to Government Decree No. 453 / 2004 Coll.
1.
Form for notification of a person handling in vitro diagnostics referred to in § 11 (6) of Government Decree No. 453 / 2004 Coll., as amended by Government Decree No. 67 / 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. 13
Annex No. 13 to Government Decree No. 453 / 2004 Coll.
1.
In vitro diagnostic notification form
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:
2.2.1. information relating to:
2.2.1.1. reagents, reagent response results, calibration and control materials, taking into account their general technological characteristics; or
2.2.1.2. Analysts and any other significant changes thereto, including interruption of marketing;
2.2.1.3 other in vitro diagnostics with relevant data,
2.2.2. for in vitro diagnostics listed in Annex 2 to this Regulation and in vitro diagnostics for self-testing
2.2.2.1. Data enabling their identification,
2.2.2.2. Information on their labelling (e.g. CE marking, labels, symbols, inscriptions),
2.2.2.3. Instructions for their use,
2.2.2.4. Analytical and, where applicable, basic diagnostic data referred to in point 3 of Part A. of Annex No 1 to this Regulation,
2.2.2.5. results of the performance evaluation referred to in Annex 8 to this Regulation,
2.2.2.6. certificates; and
2.2.2.7. substantial changes relating to points 2.2.2.1 to 2.2.2.6. including interruption of marketing.
2.3. If the person making 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 the authorisation to act. ';
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. 67 / 2011 Coll., amending Government Regulation No. 453 / 2004 Coll., laying down technical requirements for in vitro diagnostic medical devices, as amended by Government Regulation No. 246 / 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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