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Implement MDR QMS & Lodge NB Application
April 13, 2023

Regulation 2023/607 Published

April 7, 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:

 

  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.

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