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

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

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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