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European Commission proposes postponement of the new EU Medical Device Regulation and broadens Emergency Use Authorization Rules

Alert April 6, 2020

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  • European Commission proposes postponement of the new EU Medical Device Regulation and broadens Emergency Use Authorization Rules

European Commission proposes postponement of the new EU Medical Device Regulation and broadens Emergency Use Authorization Rules

April 6, 2020, Covington Alert

On April 3, 2020, the European Commission published its proposal for a new Regulation to amend the application date of the Medical Devices Regulation 2017/745 (“MDR”) by one year. The proposed new legislation also amends the MDR rules on exceptional special authorizations of non-CE-marked medical devices with immediate effect.

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