Commission’s own report points to MDR/IVDR crisis ahead

At the 24 October meeting of the MDCG, some alarming, but not unexpected, details relating to notified body capacity in the run-up to the final days of implementation of the Medical Device Regulation (MDR, 2017/745) and the In Vitro Diagnostic Regulation (IVDR, 2017/746) were presented by the European Commission following a survey of notified bodies.

The presentation itself, titled ‘Notified Bodies Survey on certifications and applications (MDR/IVDR)’ can be accessed from here.

Readers will see that less than 6,000 AIMDD/MDD certificates are due to expire during 2022/23, but over 17,000 are due to expire in the first 5 months of 2024, with the probability that the majority of these will expire on the last day allowable: 26 May. In the meantime, as of October 2022, less than 2,000 MDR certificates have been issued, with just over 8,000 applications received. The math is not looking optimistic for all current devices to be MDR-compliant by mid-2024.

The situation is no better for IVDs, with 865 certificates due to expire by mid-2025 and less than 700 due to expire between 2022 and 2024, compared with 268 certificates issued by the 7 notified bodies designated to date for the IVDR, with 822 applications. These figures largely ignore that fact that around 805 of the IVDs that were self-certified under the IVDD will now require the input of a notified body, so again the math does not favour a smooth, trouble-free transition to IVDR CE-compliance over the next 5 years.