Episode 5 – Medical Devices – Key Recent Developments

25/04/2023 13 min Temporada 1 Episodio 5
Episode 5 – Medical Devices – Key Recent Developments

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Episode Synopsis

In this episode of Covington's Life Sciences Podcast, Sarah Cowlishaw and Ellie Handy discuss the recent changes to the MDR and IVDR.  Our speakers discuss the European Commission's recently adopted Regulation (EU) 2023/607, which extends the transitional periods in the EU Medical Devices Regulation (EU) 2017/745 (the "MDR") for certain eligible devices CE marked under the previous directives.  The Regulation also removes the "sell-off" periods for devices and in vitro diagnostic devices from both the MDR and In Vitro Diagnostic Device Regulation (EU) 2017/746 (the "IVDR").  Our team discuss how these provisions will apply and the practical implications of the changes for the medical device sector in the EU and UK.

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