The European Commission proposal for the MDR delay is now officially published and accessible through: https://ec.europa.eu/commission/presscorner/detail/en/ip_20_589
Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions modifies current MDR provisions as follows:
- Article 1(2): Necessary common Specifications for Annex XVI devices shall be adopted by 26 May 2021 instead of 26 May . . .
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