No. 90/2016 Coll.
(current version)

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

(EU) 2017/746
in PDF format
as of January 10, 2026, including amendment (EU) 2024/1860

Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
// partially repeals and replaces Directive 98/79/EC as of May 26, 2022; for exceptions, see Article 112
// Amendment (EU) 2023/503 applies from March 11, 2023
// Amendment (EU) 2023/607 applies from March 20, 2023
// Amendment (EU) 2024/1860 applies from July 9, 2024

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. 56/2015 Coll.
repealed

Government Regulation on Technical Requirements for In Vitro
Diagnostic Medical Devices // An in vitro diagnostic medical device placed on the market prior to the effective date of this Regulation (i.e., April 1, 2015) in accordance with existing legal regulations is considered an in vitro diagnostic medical device placed on the market in accordance with this Regulation

 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

No. 375/2022 Coll.

Act on Medical Devices and In Vitro
Diagnostic Medical Devices / December 22, 2022 repeals and replaces Decree No. 62/2015 Coll., Decree No. 171/2021 Coll., and Government Regulation No. 56/2015 Coll
./ The amendment by Act No. 241/2024 Coll. shall apply 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 / effective as of December 22, 2022
/ On December 22, 2022, it repeals and replaces Decree No. 97/2022 Coll.

No. 378/2022 Coll.

Decree on the template for the inspector’s ID card of the State Institute for Drug Control pursuant to the Act on Medical Devices and In Vitro Diagnostic Medical Devices