Government Decree No. 337 / 2001 Coll.
Government Regulation amending Government Regulation No. 191 / 2001 Coll., laying down technical requirements for active implantable medical devices
Valid
Regulation
Effective from 20.09.2001
Text versions:
20.09.2001
337
GOVERNMENT REGULATION
of 5 September 2001
amending Government Regulation No. 191 / 2001 Coll., laying down technical requirements for active implantable medical devices
The Government orders pursuant to § 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 on the Implementation of Act No. 123 / 2000 Coll., on Medical Devices and on the Amendment of Certain Related Acts:
Government Decree No. 191 / 2001 Coll., laying down technical requirements for active implantable medical devices, is amended as follows:
1. in Article 3 (e), the words "natural or legal person with registered office, place of business or permanent residence" shall be replaced by "natural person with permanent residence or place of business or legal person with registered office."
2. in Article 5 (1) (a) (2), the word "EC" shall be inserted after the word "issued."
3. In Paragraph 13 (4), "2 and 4 'is replaced by" 2 and 4 or 3 and 5'.
4. In Article 17 (1) (b), the words "or No 11 'shall be inserted after the words" and the Constitution'.
5. in Paragraph 18 (2) (a), "2 to 10" is replaced by "2, 4, 6 and 8."
6. in Article 18 (2) (b) and (c), "3 to 11" is replaced by "3, 5, 7 and 9."
7. in Article 22 (a), the words "Article 12 (b)" shall be deleted;
8. In Annex 3, point 6.3, the words "this Annex 'are replaced by the words" Annex 2 to this Regulation'.
9. In Annex 4, point 7.3, the word "EC 'is deleted.
10. In Annex 5, point 6, the word "EC 'shall be inserted after the word" (consent of an authorised person)'.
11. In Annex 7, point 6.5, the word "EC 'is inserted after the word" submission'.
12. In the first sentence of point 2 of Annex 9, the words "Declaration of conformity with type 'are replaced by the words" EC declaration of conformity with type'.
13. In Annex 11, point 2 is deleted and point 3 becomes point 2.
14. In Annex 11, point 2, the word "dossier 'is replaced by the word" dossier' and the words "table 3 'is replaced by" table 2 and 3'.
15. in Annex No 12, point 1.1, '4.2.5' is replaced by '4.2' and '3.7' is replaced by '3';
16. In Annex 13, points 1 and 3.1, "2 to 8 'is replaced by" 2, 4, 6 and 8 or 3, 5, 7 and 9'.
Certificates or other documents of authorised persons and written declarations of conformity of the characteristics of medical devices with the relevant technical regulations and of compliance with the prescribed conformity assessment procedure issued pursuant to Government Regulation No. 198 / 1999 Coll., laying down technical requirements for active implantable medical devices, shall remain in force, unless amended or repealed under the conditions laid down in Act No. 22 / 1997 Coll., on technical requirements for products and amending and supplementing certain acts, as amended by Act No. 71 / 2000 Coll.
This Regulation shall enter into force on the day of its publication.
Prime Minister:
v. PhDr. Špidla v. r.
1. Deputy Prime Minister
and Minister for Labour and Social Affairs
Minister for Health:
Prof. MUDr. Fisher, CSc.
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Regulation Information
| Citation | Government Regulation No. 337 / 2001 Coll., amending Government Regulation No. 191 / 2001 Coll., laying down technical requirements for active implantable medical devices |
|---|---|
| Regulation Type | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 20.09.2001 |
|---|---|
| Effective from | 20.09.2001 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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