Decree No. 336 / 2001 Coll.
Government Regulation amending Government Regulation No. 181 / 2001 Coll., laying down technical requirements for medical devices
Valid
Regulation
Effective from 20.09.2001
Text versions:
20.09.2001
336
GOVERNMENT REGULATION
of 5 September 2001
amending Government Regulation No 181 / 2001 Coll., laying down technical requirements for 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 Regulation No. 181 / 2001 Coll., laying down technical requirements for medical devices, is amended as follows:
1. In Article 5 (2), the words "natural or legal person with registered office 'are replaced by the words" natural person with permanent residence or place of business or legal person with registered office'.
2. In Article 7 (2), "II, VI, XII and XIV 'is replaced by" II, IV, VI, VIII, X and XII';
3. in Article 7 (3), "III, VII, XIII and XV" is replaced by "III, V, VII, IX, XI and XIII";
4. In Article 9 (3), the introductory phrase of point (b) reads:
"(b) EC type-examination in accordance with Annex V to this Regulation in conjunction with the pro-procedure."
5. in Paragraph 9 (3) (b) (1):
"1. EC verification in accordance with Annex VII to this Regulation,"
6. In Article 10 (4), "II, III, IV or V 'is replaced by" II and IV or III and V'.
7. In Article 15 (1), the words "and the Constitution 'shall be inserted after the words" the Ministry'.
8. in Paragraph 19 (b), the figures "III, V, VII, XIII and XV" are replaced by "III, V, VII, IX, XI, XIII and XV."
9. In Article 19 (b), the words "in these Annexes' are deleted.
10. In Annex V, point 2.2, "2.3 'is replaced by" 2.2' and in point 2.3, "2.4 'is replaced by" 2.3'.
11. In Annex VIII, point 5.1.5, "3.4 'and" a' are inserted after the word "points'.
12. In Annex IX, point 5.1.5, the numbers "4.3 and 4.4 'are replaced by" 3.4 and 4.3'.
13. In Annex IX, paragraph 5.1.6, "IV 'is replaced by" V'.
14. In Annex IX, point 6.1, the word "requirements' is replaced by" requirements'.
15. in Annex X, point 2.2, the word "No" shall be inserted after the word "Annex."
16. In Annex XI, point 2.2, the figure "VIII 'is replaced by the figure" IX' and in point 5.1.5, the figure "IV 'is replaced by the figure" V'.
17. In Annex XIII, points 5 and 6.1, the text "VI, VIII or X 'is replaced by the text" VII, IX or XI'.
18. In Annex XVIII, point 1, "II and X 'is replaced by" II to XI' and in point 3.1, "II to X 'is replaced by" II to XI'.
19. in Annexes No XIX, XX, XXI and XXII, the words "responsible representative" are replaced by the words "authorised representative."
20. In Annex XX to the entry 1580, the words "Section 10 'are replaced by" Section 11' and the text "180 / 1998 'is replaced by the words" 181 / 2001'.
21. In Annex XXII, entry 5250, the text "198 / 1999 Coll., as amended 'is replaced by" 191 / 2001 Coll.' and the text "180 / 1998 Coll., as amended 'is replaced by" 181 / 2001 Coll.'.
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 Decree No. 180 / 1998 Coll., laying down technical requirements for medical devices, as amended by Government Decree No. 130 / 1999 Coll., remain valid, 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 Decree No. 336 / 2001 Coll., amending Government Decree No. 181 / 2001 Coll., laying down technical requirements for 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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