Act No. 22/1997 Coll., on Technical Requirements for Products

Main information

Implemented directive

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


the Act stipulates technical requirements for medical devices (products) and accreditation of conformity assessment bodies

Related legislation

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