Act No. 376 / 2022 Coll.
Law amending certain laws in connection with the adoption of the Law on in vitro medical devices and diagnostic medical devices
Valid
Law
Effective from 22.12.2022
Text versions:
22.12.2022
07.12.2022
376
THE LAW
of 3 November 2022
amending certain laws in connection with the adoption of the Law on in vitro medical devices and diagnostic medical devices
Parliament has decided on this law of the Czech Republic:
Amendment of the Administrative Charges Act
Act No. 100 / 2009, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2008, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2011, Act No. 100 / 2008, Act No. 100 / 2008, Act No. 100 / 2008, Act No. 2011, Act No. 100 / 2008, Act No. 100, Act No. 2011, Act No. 100, Act No. 2011, Act No. 100, Act No. 2011, Act No. 100, Act No. 2011, Act No. 2011, Act No. 2011, Act No. 2011, Act No. 2011, Act No. 2011, No. 2011, No. 2011, No. 2011, No. 2011, No. 2011, No. 2011, Act No. 2011, Act No. 2011, Act No. 2011, No. 2011, Act No. 2011, No. 2011, Act No 5 / 2016, Act No. 13 / 2016, Act No. 13 / 2016, Act No. 13 / 2016, Act No. 13 / 2016, Act No. 13 / 2016, Act No. 13 / 2016, Act No. 13 / 2016, Act No. 13 / 2016, Act No. 13 / 2016, Act No. 13 / 2015, Act No. 13 / 2015, Act No. 13 / 2015, Act No. 13 / 2015, Act No. 13 / 2015, Act No. 13 / 2015, Act No. 13 / 2015, Act No. 13 / 2015, Act No. 13 / 2015, Act No. 13 / 2015, Act No. 13 / 2015, Act No. 13 / 2015 / 2015, Act No. 13 / 2015, Act No. 13 / 2015, Act No. 13 / 2015, Act No. 13 / No 2015, Act No. 15 / 2015, Act No. 15 / 2015, Act No. 13, Act No. 15 / 2015, Act No. 13, Act No. 13, Act No. 13, Act No. 13 / 2016, Act No 2015, Act No 2015, Act No 2015, Act No 2015, Act No 2015, Act No 2015, Act No 2015 / 2016, No 2015, No 2015, Act No No 2015, No 2015, No 2015, No 2015, No 2015, No 2015, No
1. in entry 97, point 3 is deleted;
Points 4 and 5 shall become points 3 and 4.
2. In point 3 of point 97, the words "or the verification of the data referred to in Article 28 (1) of Regulation (EU) 2017 / 746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98 / 79 / EC and Commission Decision 2010 / 227 / EU (in vitro diagnostic medical devices Regulation) and the allocation of a single registration number as referred to in point 2 of Article 28 of the in vitro diagnostic medical devices Regulation by manufacturers, authorised representatives or importers' shall be inserted after the words" importers'.
3. In entry 97 (4) (b), the word "medical 'is deleted and the words" in vitro medical devices and diagnostic medical devices' are inserted after the word "devices'.
4. In entry 97 (4) (c), the word "medical 'is deleted and the words" in vitro medical devices and diagnostic medical devices' are inserted after the word "devices'.
5. in point 97 (4) (e), the words "or the authorisation of an in vitro diagnostic medical device 'shall be inserted after the word" device'.
6. in point 97 (4) (f), the words "or in vitro diagnostic medical device free-selling certificate 'are inserted after the word" device';
Amendment to the Advertising Regulation Act
Act No. 5 / 2011 Coll., Act No. 138 / 2002 Coll., Act No. 20 / 2002 Coll., Act No. 20 / 2008 Coll., Act No. 20 / 2008 Coll., Act No. 21 / 2009 Coll., Act No. 25 / 2006 Coll., Act No. 25 / 2006 Coll., Act No. 109 / 2007 Coll., Act No. 160 / 2007 Coll., Act No. 36 / 2008 Coll., Act No. 21 / 1995 Coll., Act No. 21 / 1995 Coll.
1. At the end of footnote 1, the sentence "Article 7 of Regulation (EU) 2017 / 746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Council Directive 98 / 79 / EC and Commission Decision 2010 / 22 / EU shall be added to the separate line. '
2. In Paragraph 5k (2) (b), the word "do not contain 'is replaced by" contain only the essential' and the words "necessary for identification 'are added at the end of the text (b).
3. In Section 5k (3), the words "other legislation regulating diagnostic medical devices in vitro43) 'are replaced by the words" Regulation (EU) 2017 / 74643 of the European Parliament and of the Council'.
Footnote 43 reads:
"(43) Regulation (EU) 2017 / 746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98 / 79 / EC and Commission Decision 2010 / 227 / EU."
4. In Paragraph 5k (4), the word "Regulation 'is replaced by" Article 21 (3) of the Regulation'.
5. In Section 5k (5), the words "Regulation (EU) 2017 / 74643 of the European Parliament and of the Council 'shall be inserted after the words" placing on the market'; the words "visibly 'shall be deleted; the words" cannot be placed on the market or put into service' shall be deleted; Such in vitro diagnostic medical devices shall not be used on samples originating from participants in the action as referred to in the first sentence 'shall be replaced by' in accordance with Article 19 (3) of Regulation (EU) 2017 / 74643 of the European Parliament and of the Council '.
6. Paragraph 5 (6) is deleted.
Paragraphs 7 and 8 shall be renumbered paragraphs 6 and 7.
7. In Article 5l (3) (c), the words "intended purpose 'are replaced by the words" nature of the intended purpose'.
8. At the end of the heading § 5m, the words "and staff of the health service provider 'are added.
9. In Section 5m (1) of the Introductory Part of the provision, the words "and staff of the health service provider 'shall be inserted after the words" and staff of the health service provider'; the words "those experts' shall be replaced by the words" those persons' and the words "or by direct communication with them 'shall be inserted after the words" to the experts'.
10. in Article 5m (1) (a), the word "experts" shall be deleted; the words "safety and efficacy" shall be inserted after the words "clinical benefit" and the comma shall be replaced by a dot at the end of point (a);
11. in § 5m, point (b) is deleted and the designation (a) is deleted.
12. in Article 5m (2) and (5), the words "and staff of the health service provider" shall be inserted after the words "experts."
13. in Article 5m (3), the words "and staff of the health service provider" shall be inserted after the words "than experts."
14. in Article 5m (4), the words "and staff of the health service provider" shall be inserted after the word "Experts."
15. In Article 7, the words "and Article 7 of Regulation (EU) 2017 / 74643 of the European Parliament and of the Council" shall be added at the end of the text in point (b) to the extent that it concerns advertising on in vitro diagnostic medical devices. "
16. in Article 8 (2) (b), "§ 5k (3), (4), (5), (6), (7) or (8)" is replaced by "§ 5k (3), (4), (5), (6) or (7)" and the words "or in Regulation (EU) 2017 / 74643 of the European Parliament and of the Council" shall be added at the end of the text of point (b). "
17. in Article 8 (3) (d), "§ 5k (3), (4), (5), (6), (7) or (8)" is replaced by "§ 5k (3), (4), (5), (6) or (7)" and the words "or in Regulation (EU) 2017 / 74643 of the European Parliament and of the Council" shall be added at the end of the text of point (d). "
18. in Article 8a (2) (d), the text "§ 5k (3), (4), (5), (6), (7) or (8)" is replaced by "§ 5k (3), (4), (5), (6) or (7)" and the words "or in Regulation (EU) 2017 / 74643 of the European Parliament and of the Council" are added at the end of the text of point (d). "
19. in Article 8a (3) (d), the text "§ 5k (3), (4), (5), (6), (7) or (8)" is replaced by "§ 5k (3), (4), (5), (6) or (7)" and the words "or in Regulation (EU) 2017 / 74643 of the European Parliament and of the Council" are added at the end of the text of point (d). "
EFFECTIVE
This Act shall take effect on the 15th day following its publication.
Pekarová Adamová v. r.
Zeman v. r.
Fiala v. r.
Contents
Sign in for notes, favorites and notifications
Regulation Information
| Citation | Act No. 376 / 2022 Coll., amending certain laws relating to the adoption of the Law on in vitro medical devices and diagnostic medical devices |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 07.12.2022 |
|---|---|
| Effective from | 22.12.2022 |
| Effective until | - |
| Status | Valid |
Parliamentary Paper:
Paper No. 168
Public Contracts 3
Kupní smlouva - Systém pro chlazení pokožky hlavy onkologických pacientů
Oblastní nemocnice Náchod a.s.
DN FORMED Brno s.r.o.
838 324 CZK
21.08.2024
Objednávka zboží - zdravotnický materiál
Fakultní nemocnice v Motole
Videris s.r.o.
135 700 CZK
21.11.2023
Objednávka zboží - zdravotnický materiál
Fakultní nemocnice v Motole
Lima CZ s.r.o.
57 730 CZK
10.11.2023
Source:
Hlídač státu
(CC BY 3.0 CZ)
The regulation text is for informational purposes only.
Comments 0