Government Decree No. 26 / 2004 Coll.
Government Regulation amending Government Decree No. 181 / 2001 Coll., laying down technical requirements for medical devices, as amended by Government Decree No. 336 / 2001 Coll.
Valid
Effective from 23.01.2004
26
GOVERNMENT REGULATION
of 17 December 2003
amending Government Regulation No 181 / 2001 Coll., laying down technical requirements for medical devices, as amended by Government Regulation No 336 / 2001 Coll.
The Government orders pursuant to Section 22 of Act No. 22 / 1997 Coll., on 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., on the implementation of § 11 paragraphs 1 and 2, § 11a, 12 and 13 of the Act and on 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. and Act No. 274 / 2003 Coll.:
In Annex XVI to Decree-Law No 181 / 2001 Coll., laying down technical requirements for medical devices, as amended by Decree-Law No 336 / 2001 Coll., the following text is added at the end of Part III - Classification:
"6. Rule 19.
By way of derogation from other classification rules, breast implants belong to Class III. ';
Transitional provision
For breast implants placed on the market before the date of entry into force of this Regulation for which conformity as for Class IIb medical devices has been assessed, conformity as for Class III medical devices shall be reassessed by 1 March 2004 at the latest. The validity of certificates of notified persons and other decisions made by them before the date of entry into force of this Regulation concerning breast implants for which conformity as for Class IIb medical devices has been assessed shall not be extended.
Efficacy
This Regulation shall enter into force on the day of its publication and shall expire on the date of the entry into force of the Treaty of Accession of the Czech Republic to the European Union.
Prime Minister:
PhDr. Špidla v. r.
Minister for Health:
Dr. Součková v. r.
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Regulation Information
| Citation | Government Decree No. 26 / 2004 Coll., amending Government Decree No. 181 / 2001 Coll., laying down technical requirements for medical devices, as amended by Government Decree No. 336 / 2001 Coll. |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 23.01.2004 |
|---|---|
| Effective from | 23.01.2004 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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