Regulation (EU) 2023/607 Published

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:

1. For devices with expired MDD/AIMDD CE Marking certificates to be considered valid and remain on the market.
2. For Class III implantable custom-made devices to be granted an extension to comply with the MDR.

Certain conditions apply.