European Medical Device Regulation 2017

The adoption in april 2017 of regulation eu 2017 745 on medical devices mdr and regulation eu 2017 746 on in vitro diagnostic devices ivdr changed the european legal framework for medical devices introducing new responsibilities for ema and for national competent authorities. Regulation eu 2017 745 is a regulation of the european union on the clinical investigation and sale of medical devices for human use. The european parliament and council have approved a proposal to delay the full implementation of the medical device regulation 2017 745 mdr for one year to 26 may 2021.

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On april 5 2017 the eu adopted the new medical device regulation replacing the two existing directives the medical devices directive and the active implantable medical devices directive.

European medical device regulation 2017.

On medical devices amending directive 2001 83 ec regulation ec no 178 2002 and regulation ec no 1223 2009 and repealing council directives 90 385 eec and 93 42 eec text with eea relevance the european parliament and the council of the european union. Regulation eu 2017 745 of the european parliament and of the council. Regul ation eu 2017 745 of the european parliament and of the council of 5 apr il 2017 on medical devices amending directive 2001 83 ec regulation ec no 178 2002 and regulation ec no 1223 2009 and repealing council directives 90 385 eec and 93 42 eec text with eea relevance. It repeals directive 93 42 eec which concerns medical devices and directive 90 385 eec which concerns active implantable medical devices on 26 may 2021.

Legally non binding guidance documents adopted by the medical device coordination group mdcg in accordance with article 105 of regulation 745 2017 pursue the objective of ensuring uniform application of the relevant provisions of the regulations within the eu. Regulation eu 2017 745 of the european parliament and of the council of 5 april 2017 on medical devices amending directive 2001 83 ec regulation ec no 178 2002 and regulation ec no 1223 2009 and repealing council directives 90 385 eec and 93 42 eec. This means that the full. Of 5 april 2017.

Regulation eu 2017 745 of the european parliament and of the council of 5 april 2017 on medical devices amending directive 2001 83 ec regulation ec no 178 2002 and regulation ec no 1223 2009 and repealing council directives 90 385 eec and 93 42 eec text with eea relevance. Regulation eu 2017 745 the european union medical device regulation of 2017 if you are a manufacturer authorised representative importer or distributor of medical devices in the eu or a regulatory affairs or quality management professional involved with medical devices you need to know how to comply. The new medical device regulation will enter into force after a four year transition period ending on may 25 2021. Mdcg work in progress.

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