On 6 January 2023, the EU Commission published its draft legislative proposal to amend the transitional provisions in Regulation (EU) 2017/745 for medical devices (“MDR”) and Regulation (EU) 2017/746 (“IVDR”) for in vitro diagnostic medical devices, hereafter “the Regulations”.

The proposed amendments introduce an extension to the transitional periods established in the Regulations to provide medical device manufacturers more time to bring their devices into conformity with the requirements of the Regulations.

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