Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 ()
eira:concepteira:SolutionBuildingBlock
dct:modified2024-01-17
dct:identifierhttp://data.europa.eu/eli/reg/2017/746/2023-03-20
dct:titleRegulation (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 (Text with EEA relevance)Text with EEA relevance
dct:descriptionRegulation (EU) 2017/746 lays down rules concerning the placing on the market, making available on the market or putting into service of in vitro diagnostic medical devices for human use and accessories for such devices in the Union. This Regulation also applies to performance studies concerning such in vitro diagnostic medical devices and accessories conducted in the Union.
dct:publisherEUR-Lex
dct:sourcehttp://data.europa.eu/eli/reg/2017/746/2023-03-20
eira:viewLV-Architecture Principles
eira:viewLV-Binding Power and Jurisdiction
eira:businessDomainhealth
eira:eifLayerLegal
eira:implementedByhttp://data.europa.eu/dr8/BindingInstrumentRequirement