Table of content
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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
https://www.zakonyprolidi.cz/cs/1997-22
Scope
the Act stipulates technical requirements for medical devices (products) and accreditation of conformity assessment bodies