Transition to MDR – issues with Notified Bodies

A recent MDCG position paper, “Notice to manufacturers to ensure timely compliance with MDR requirements” (MDCG 2022 -11), indicated that data provided in April 2022 by Notified Bodies show that 90% of currently valid AIMDD/MDD certificates will expire in 2023-2024.

We are aware of the lack of capacity in the limited number of Notified Bodies and that for some companies this could mean a gap between when their AIMDD/MDD certificates expire and when they secure their MDR certification, which would result in their products having to be removed from the market temporarily.

Medilink and relevant trade associations are in discussion with the MHRA on this issue and we would like to better understand the scale of the problem. If your company is in a position where you believe it is likely that there will be such a gap, specifically due to the delays experienced with Notified Body capacity, please let us know at regulation@medilink.co.uk.

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