Act No. 89 / 2021 Coll.
Act on Medical Devices and Amendment to Act No. 378 / 2007 Coll., on Medicines and on Changes to Certain Related Acts (Law on Medicines), as amended
Valid
Law
Effective from 26.05.2021
89
THE LAW
of 9 February 2021
on medical devices and amending Act No. 378 / 2007 Coll., on Medicines and on Changes to Certain Related Acts (Law on Medicines), as amended
Parliament has decided on this law of the Czech Republic:
Amendment to the Drug Act
Act No. 378 / 2007 Coll., Act No. 141 / 2009 Coll., Act No. 281 / 2009 Coll., Act No. 291 / 2009 Coll., Act No. 75 / 2011 Coll., Act No. 375 / 2011 Coll., Act No. 50 / 2013 Coll., Act No. 70 / 2013 Coll., Act No. 250 / 2014 Coll., Act No. 80 / 2015 Coll., Act No. 24 / 2016 Coll., Act No. 65 / 2017 Coll., Act No. 66 / 2017 Coll., Act No. 183 / 2017 Coll., Act No. 251 / 2017 Coll., Act No. 36 / 2018 Coll., Act No. 44 / 2019 Coll., Act No. 262 / 2019 Coll., amended as follows:
1. In Paragraph 81 (1), at the end of point (f), the word "a 'is replaced by a comma.
2. In Paragraph 81, at the end of paragraph 1, the dot is replaced by "a 'and the following point (h) is added:
"(h) the central repository of electronic vouchers under another legislation117).
117) Act No. 89 / 2021 Coll., on Medical Devices and amending Act No. 378 / 2007 Coll., on Medicines and on Changes to Certain Related Acts (Act on Medicines), as amended. '
3. in Article 81 (4) (a), the words "surname and" shall be replaced by "surname," and the words "place of residence" shall be inserted after the words "birth."
4. In Article 81 (4) (b), the words "surname and 'are replaced by the words" surname,' and the words "birth 'are replaced by the words" and the address of the place of residence'.
5. In Section 81a (1), the sentence "The medical and pharmaceutical access data referred to in the first sentence may be replaced by proof of identity using the National Identification and Authenticaci118 services' is inserted after the first sentence and the sentence" Other persons, if other legislation118 so provides' is inserted after the third sentence.
Footnote 118 reads as follows:
"118) Act No. 250 / 2017 Coll., on Electronic Identification, as amended. '.
EFFECTIVE
This Act shall take effect on 26 May 2021.
Vondracek v. r.
Zeman v. r.
Babiš v. r.
(1) Regulation (EU) 2017 / 745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001 / 83 / EC, Regulation (EC) No 178 / 2002 and Regulation (EC) No 1223 / 2009 and repealing Council Directives 90 / 385 / EEC and 93 / 42 / EEC.
2) Act No. 22 / 1997 Coll., on technical requirements for products and amending and supplementing certain laws, as amended. Act No. 90 / 2016 Coll., on conformity assessment of specified products when making them available on the market., as amended.
3) Act No. 90 / 2016 Coll., as amended.
4) Article 2 (12) of the Regulation on medical devices.
5) Article 30 of the Regulation on medical devices.
6) Part 7 of Act No. 48 / 1997 Coll., on Public Health Insurance and on the amendment and addition of certain related laws, as amended.
7) Act No. 40 / 1995 Coll., on the regulation of advertising, as amended.
8) Annex No I, Chapter III, point 23.2 (i) of the Regulation on medical devices.
9) Article 3 of Act No. 505 / 1990 Coll., on Metrology, as amended.
10) Paragraph 94 (2) of Act No. 221 / 1999 Coll., on Professional Soldiers, as amended.
11) Article 43 of Constitutional Act No. 1 / 1993 Coll., Constitution of the Czech Republic, as amended. § 3 (1) of Act No. 300 / 2013 Coll., on Military Police and on the amendment of certain laws (Act on Military Police), as amended.
12) ČSN EN 62353 - Medical electrical equipment - Repeated tests and tests after repairs of medical electrical equipment.
13) Annex 3 to Act No. 111 / 1998 Coll., on Higher Education and amending and supplementing other laws (Act on Higher Education), as amended.
14) Act No. 255 / 2012 Coll., on Control (Control Regulations), as amended.
15) Article 2 (7) of the Regulation on medical devices.
16) Act No. 22 / 1997 Coll., as amended. Government Decree No. 179 / 1997 Coll., laying down the graphic form of the Czech conformity mark, its implementation and location on the product, as amended.
Contents
Sign in for notes, favorites and notifications
Regulation Information
| Citation | Act No. 89 / 2021 Coll., on Medical Devices and amending Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Law on Medicines), as amended |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 01.03.2021 |
|---|---|
| Effective from | 26.05.2021 |
| Effective until | - |
| Status | Valid |
Public Contracts 5
Rámcová kupní smlouva o dodávkách zboží
Nemocnice Český Krumlov, a.s.
REJA spol. s r.o.
05.02.2026
Notifications
Dodatek ke smlouvě o dílo.
Domov Štíty - Jedlí, příspěvková organizace
AquariusD, společnost osob založená podle §2716 Zá...
487 630 CZK
10.12.2025
Notifications
Dodatek ke smlouvě o dílo.
Domov Štíty - Jedlí, příspěvková organizace
AquariusD, společnost osob založená podle §2716 Zá...
100 000 CZK
22.10.2025
Notifications
Dodatek ke smlouvě o dílo
Domov Štíty - Jedlí, příspěvková organizace
AquariusD, společnost osob založená podle §2716 Zá...
96 800 CZK
07.10.2024
Notifications
BTK dle zák. 89/2021 Sb. skiaskopicko-skiagrafického digitálního RTG systému
Nemocnice Na Františku
Siemens Healthcare, s.r.o.
66 187 CZK
06.03.2023
Source:
Hlídač státu
(CC BY 3.0 CZ)
The regulation text is for informational purposes only.
Comments 0