Government Regulation No. 246 / 2009 Coll.
Government Regulation amending Government Regulation No. 453 / 2004 Coll., laying down technical requirements for in vitro diagnostic medical devices
Valid
Regulation
Effective from 05.08.2009
Text versions:
05.08.2009
246
GOVERNMENT REGULATION
of 13 July 2009
amending Government Regulation No. 453 / 2004 Coll., laying down technical requirements for in vitro diagnostic medical devices
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 Acts, as amended by Act No. 71 / 2000 Coll. and Act No. 205 / 2002 Coll., on the Implementation of Sections 11 to 13 of the Act and on the Implementation of Act No. 123 / 2000 Coll., on Medical Devices and on the Amendment of Certain Related Acts, as amended by Act No. 130 / 2003 Coll., Act No. 274 / 2003 Coll. and Act No. 58 / 2005 Coll.:
Government Regulation No. 453 / 2004 Coll., laying down technical requirements for in vitro diagnostic medical devices, is amended as follows:
1. Paragraph 7 (3), including footnote 12a, reads as follows:
"(3) The common technical specifications are laid down in the directly applicable legislation of the European Communities 12a).
12a) Commission Decision 2002 / 364 / EC of 7 May 2002 on common technical specifications for in vitro diagnostic medical devices. Commission Decision 2009 / 108 / EC of 3 February 2009 amending Decision 2002 / 364 / EC on common technical specifications for in vitro diagnostic medical devices. '
2. Annex 10 is deleted.
Efficacy
This Regulation shall enter into force on the day of its publication.
Prime Minister:
Ing. Fischer, CSc.
Minister for Health:
Mgr. Jurásková, Ph.D., MBA v. r.
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Regulation Information
| Citation | Government Regulation No. 246 / 2009 Coll., amending Government Regulation No. 453 / 2004 Coll., laying down technical requirements for in vitro diagnostic medical devices |
|---|---|
| Regulation Type | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 05.08.2009 |
|---|---|
| Effective from | 05.08.2009 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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