Medical devices as defined by

Regulation (EU) 2017/745 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 and Council Directive 98/79/EC on in vitro diagnostic medical devices 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

Draft Act on medical devices and in vitro diagnostic medical devices

A draft act is being submitted that takes over the adaptation of Regulation (EU) 2017/745 of the European Parliament and of the Council, implemented by Act No 89/2021 on medical devices, while adapting to almost the same extent Regulation (EU) 2017/746 of the European Parliament and of the Council.
The Czech Republic’s legal code is supplemented by provisions that are left to the competence of each Member State by the Regulations, in accordance with the texts of the Regulations. At the national level, the draft thus implements both Regulations through identical legislation in one Act, as they allow.

The draft Act on medical devices and in vitro diagnostic medical devices provides for the same competence of administrative bodies in the performance of state administration in the field of medical devices and in vitro diagnostic medical devices.
Beyond adaptation, the proposal regulates the issue of prescription, dispensing and servicing of medical devices.
The present draft refers in a footnote to ČSN EN 62353 EN 61010-2-101ed.2, catalogue number 97147.
Keywords:
medical device, in vitro medical device