Government Regulation No. 54/2015 Coll., on Technical Requirements for Medical Devices

Main information

Contact details of the competent authorities and authorities responsible for supervising the implementation

Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Law type

National implementation rules (incuding national transpositions of EU directives and may also include regulations)

Direct link to rule

https://www.zakonyprolidi.cz/cs/2015-54

Scope

the Regulation stipulates the technical requirements for medical devices