Czech Republic Regulations on Medical Devices

No. 90/2016 Coll.
(current version)

Act on the Conformity Assessment of Specified Products When Placed on the Market /
Amendment by Act No. 236/2024 Coll. effective as of August 7, 2024; for exceptions, see Article V

(EU) 2017/745, text in PDF format as of January 1, 2026, without amendment
(EU) 2023/2197

Regulation of the European Parliament and of the Council 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
/ The Regulation applies from May 26, 2020; for exceptions, see Article 123 "Entry into force and applicability"
/ Amendment (EU) 2020/561 postpones the entry into force of certain provisions of Regulation (EU) 2017/745 by one year
/ Amendment (EU) 2023/502 applies from March 11, 2023
/ Amendment  (EU) 2023/607 applies from March 20, 2023
/ Amendment (EU) 2023/2197 applies from November 9, 2025
/ amendment (EU)2024/1860 applies from July 9, 2024 /
amendment (EU)2025/1920 applies from November 1, 2028
/ Amendment (EU) 2025/2457 applies from January 1, 2026

No. 22/1997 Coll.
(current version)

Act on Technical Requirements for Products and on Amendments to Certain Acts/
Amendment by Act No. 330/2025 Coll. applies from January 1, 2027

No. 54/2015 Coll.
repealed
on May 26, 2021
, by Act
No. 89/2021 Coll.

Government Regulation on Technical Requirements for Medical Devices

No. 375/2022 Coll.
(current version)

Act on Medical Devices and In Vitro
Diagnostic Medical Devices / December 22, 2022 repeals Decree No. 186/2021 Coll. and Decree No. 170/2021 Coll
./ amendment by Act No. 241/2024 Coll. applies from August 23, 2024

No. 377/2022 Coll.

Decree on the Implementation of Certain Provisions of the Act on Medical Devices and In Vitro Diagnostic Medical Devices

No. 89/2021 Coll.
(current version)

Act on Medical Devices and on the Amendment to Act No. 378/2007 Coll., on Medicinal Products and on Amendments to Certain Related Acts (Act on Medicinal Products), as amended

 No. 268/2014 Coll.
(current version)

Act on Medical Devices and on the Amendment to Act No. 634/2004 Coll., on Administrative Fees, as amended