Government Regulation No. 56/2015 Coll., on Technical Requirements for in vitro Diagnostic Medical Devices

Table of content

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Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

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

the Regulation stipulates technical requirements for in vitro medical devices