Implement MDR QMS & Lodge NB ApplicationApril 13, 2023
Regulation 2023/607 formally extends the Article 120 transitional provisions in the MDR. It also removes the sell-off period from the MDR and IVDR.
The extension allows, under certain criteria:
- For devices with expired MDD/AIMDD CE Marking certificates to be considered valid and remain on the market.
- For Class III implantable custom-made devices to be granted an extension to comply with the MDR.
Certain conditions apply.