Government Decree No. 212 / 2007 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
Regulation
Effective from 01.09.2007
Text versions:
01.09.2007
22.08.2007
212
GOVERNMENT REGULATION
of 11 July 2007
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
According 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"), the Government mandates the implementation of § 11 paragraphs 1 and 2, § 11a, § 12 and 13 of the Act and the 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.
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, is amended as follows:
1. In Article 1, the words "This Regulation shall be laid down in accordance with the law of the European Communities (1) 'shall be replaced by the words" This Regulation shall incorporate the relevant provisions of the European Communities (1) and shall be amended'.
Footnote 1:
"(1) Council Directive 93 / 42 / EEC of 14 June 1993 concerning medical devices, as amended by Council Directive 98 / 79 / EC of 27 October 1998, Directive 2000 / 70 / EC of the European Parliament and of the Council of 16 November 2000, Directive 2001 / 104 / EC of the European Parliament and of the Council of 7 December 2001. Commission Directive 2003 / 12 / EC of 3 February 2003 amending the classification of breast implants in the framework of Directive 93 / 42 / EEC concerning medical devices. Commission Directive 2003 / 32 / EC of the European Communities on the introduction of detailed specifications on the requirements laid down in Council Directive 93 / 42 / EEC as regards medical devices manufactured using tissues of animal origin of 23 April 2003. Regulation (EC) No 1882 / 2003 of the European Parliament and of the Council of 29 September 2003 adapting the provisions relating to committees assisting the Commission in the exercise of its implementing powers laid down in Council acts adopted in accordance with the procedure referred to in Article 251 of the EC Treaty, to the provisions of Decision 1999 / 468 / EC. Commission Directive 2005 / 50 / EC of 11 August 2005 on the reclassification of hip, knee and shoulder joints in the framework of Council Directive 93 / 42 / EEC concerning medical devices. '
2. In Annex 9, point 1.9 is replaced by the following:
"1.9." hip entrapment, knee and shoulder entrapment "means, for the purposes of this Regulation, implantable components of a total entrapment system, designed to ensure a function similar to a natural hip joint, a natural knee joint and a natural shoulder joint. This definition does not apply to auxiliary components (screws, wedges, splints or tools). ';
3. In Annex 9, the following point 7 is added at the end of Part III "Classification ':
"7. Rule 20.
By way of derogation from other rules, hip replacements, knee replacements and shoulder replacements belong to Class III. '
Transitional provisions
1. Hip replacements, knee replacements and shoulder replacements for which before 1 September 2007 a conformity assessment has been carried out pursuant to Article 9 (3) (a) of Government Regulation No 336 / 2004 Coll., shall be submitted to a supplementary conformity assessment according to point 4 of Annex 2 to Government Regulation No 336 / 2004 Coll. until 1 September 2009. This is without prejudice to the possibility of submitting a request for conformity assessment pursuant to § 9 (1) (b) of Decree No 336 / 2004 Coll.
2. Hip replacements, knee replacements and shoulder replacements for which before 1 September 2007 a conformity assessment has been carried out pursuant to § 9 (3) (b) (3) of Government Regulation No 336 / 2004 Coll., shall be submitted to a conformity assessment as Class III medical devices pursuant to § 9 (1) (b) (1) or (2) of Government Regulation No 336 / 2004 Coll. until 1 September 2010. This is without prejudice to the possibility of submitting a request for conformity assessment pursuant to Article 9 (1) (a) of Decree No 336 / 2004 Coll.
3. Hip replacements, knee replacements and shoulder replacements for which a conformity assessment has been carried out pursuant to Article 9 (3) (a) of Decree No. 336 / 2004 Coll. before 1 September 2007 may be placed on the market and put into service until 1 September 2009.
4. Hip replacements, knee and shoulder replacements for which conformity assessment has been carried out pursuant to Article 9 (3) (b) (3) of Decree No 336 / 2004 Coll. before 1 September 2007 may be placed on the market until 1 September 2010; they may be put into service after that date.
Efficacy
This Regulation shall enter into force on 1 September 2007.
Prime Minister:
Ing. Topolánek v. r.
Minister for Health:
Dr. Julinek, MBA v. r.
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Regulation Information
| Citation | Government Regulation No. 212 / 2007 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 | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 22.08.2007 |
|---|---|
| Effective from | 01.09.2007 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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