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Medical Device Regulation, IVDR , MDR, 2017/745, notified body

Exciting news for medical device manufacturers!

The amendment of Regulation (EU) 2023/607 opens up new opportunities for those transitioning their medical devices to the MDR. Legacy devices can now have the validity of their directive certificates extended (until the end of 2027/2028, depending on the device classification) if certain conditions are met.

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