Market Surveillance

The market surveillance activities of persons handling medical devices are governed by 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, and 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 and, together with them, Act No. 375/2022 Coll, on medical devices and in vitro diagnostic medical devices, as amended

Inspected subjects include health service providers in the field of medical device use, as well as manufacturers, importers, distributors, medical device servicers and dispensers. This surveillance activity also includes the agenda for assessing the correct marketing of medical devices, supervision pursuant to Act No 526/1990 Coll., on prices, as amended, for medical devices with regulated prices and supervision pursuant to Act No 634/1992 Coll., on consumer protection, as amended, when offering and selling medical devices to consumers.

The aim of the planned and unplanned inspections is to ensure that the medical devices supplied to the market in the Czech Republic are safe and functional and that healthcare is provided by safe and effective medical devices so that their correct use for the purposes for which they are intended does not harm the health of users or patients.