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What's up with the certification of Class IIb/III devices under the MDR?

End of May 2025, devices certified under the MDD can no longer be sold or distributed in EU - less than 28 months to go. Tick-tock, tick-tock...

Currently, it seems like while a majority of Class I devices, and a bit over half of Class IIa devices are well on their way; Class IIb and Class III devices, however, are not on track.

This assumption is based on data (table below) compiled from the EUDAMED database; which currently is being populated by manufacturers - and contains around 150k of the over 500k types of medical devices available on the market (source: European Commission, Medical Device Overview, Jan 2023). This includes both Medical devices and In Vitro Diagnostic medical devices.

Extrapolating, and looking only at medical devices (not in vitro devices), we can assume that the amount of medical devices that still need to transition from MDD to MDR are around 160k, thereof 146k Class IIa/IIb/III. (Note that Class I devices are not subject to audits from notified bodies.)

There are 37 notified bodies that are qualified to help companies with the transition from MDD to MDR. Given 840 days (28 months) and 146k devices, EACH of these notified bodies has to approve around 4.7 devices a day - pretty tall order it has to be said given the estimated resources these companies have.

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