Government Regulation No 223 / 2012 Coll.
Government Regulation amending Government Regulation No. 453 / 2004 Coll., laying down technical requirements for in vitro diagnostic medical devices, as amended
Valid
Regulation
Effective from 01.07.2012
223
GOVERNMENT REGULATION
of 19 June 2012
amending Government Regulation No 453 / 2004 Coll., laying down technical requirements for in vitro diagnostic medical devices, as amended
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. 205 / 2002 Coll. and Act No. 34 / 2011 Coll., for the implementation of § 11 paragraphs 1 and 2, § 11a paragraphs 2, § 12 and 13 of the Act, and for the implementation of 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., Act No. 196 / 2010 Coll.
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. and Government Regulation No. 67 / 2011 Coll., is amended as follows:
1. footnote 1 shall read:
"(1) Directive 98 / 79 / EC of the European Parliament and of the Council of 27 October 1998 concerning in vitro diagnostic medical devices. Commission Decision 2002 / 364 / EC of 7 May 2002 on common technical specifications for in vitro diagnostic medical devices. Commission Directive 2011 / 100 / EU of 20 December 2011 amending Directive 98 / 79 / EC of the European Parliament and of the Council on in vitro diagnostic medical devices. ';
2. In Annex 2 to the List A is replaced by a comma at the end of point 2 and the following point 3 is added:
"3. tests for variant Creutzfeldt-Jakob disease (vCJD) for blood, diagnosis and confirmation."
Efficacy
This Regulation shall enter into force on 1 July 2012.
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. 223 / 2012 Coll., amending Government Regulation No. 453 / 2004 Coll., laying down technical requirements for in vitro diagnostic medical devices, as amended |
|---|---|
| Regulation Type | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 26.06.2012 |
|---|---|
| Effective from | 01.07.2012 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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