The following links refer you to the most important legislative regulations that are essential for the placing medical devices on the market. These are European regulations, laws and government regulations valid for the Czech Republic and the Slovak Republic. Other legislative regulations are directly or indirectly related to medical devices and the provision of health services in the Czech Republic.

Regulation (EU) 2017/745 on medical devices

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

Czech Republic

Act No. 89/2021 Coll., on medical devices

Act No. 268/2014 Coll., on in vitro diagnostic medical devices

Act No. 22/1997 Coll., on technical requirements for products

Government Regulation No. 56/2015 Coll., on technical requirements for in vitro diagnostic medical devices

Act No. 505/1990 Coll., on metrology

Act No. 372/2011 Coll., on health services

Slovakia

Act No. 362/2011 Coll., On Medicines and Medical Devices

Government Regulation No. 569/2001 Coll., On technical requirements and conformity assessment procedures for in vitro diagnostic medical devices