Tackling the notified body shortfall

What does the EC proposal mean for MDD and IVDD certified devices?

Under the proposed amendment, the transition periods during which EC certificates issued under the MDD and IVDD would still be valid are as follows:

• Class III devices and class IIb devices (except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors) that have a valid and current EC certificate issued in accordance with the AIMDD and the MDD may be placed on the market or put into service until the 31st of December 2027.
• Remaining class IIb devices, class IIa devices, class I sterile devices, and class I devices with a measuring function that have a valid and current EC certificate may be placed on the market or put into service until the 31st of December 2028.
• Other class I devices not requiring the involvement of a notified body are not impacted by this proposal.

The availability of medical devices in the EU

The proposed amendment seeks to delete the ‘sell off’ deadline contained within both the MDR and IVDR, thereby allowing devices placed on the market after the end of the transition period to continue being sold until their actual expiration date.

This proposal is being driven by a realisation on the part of the European Commission that the current overall capacity of notified bodies remains insufficient to carry of the tasks required of them, coupled with the fact that many manufacturers are not sufficiently prepared to meet the strengthened requirements of the MDR by the end of the transition period. This lack of capacity has been identified as a real threat to the continued availability of medical devices on the EU market.

The commission’s proposal identifies a total of 36 notified bodies currently designated under the MDR; with a further 26 applications currently being processed. As of October 2022, notified bodies reported they had received altogether 8,120 applications from manufacturers for certification under the MDR and had issued 1,990 certificates in accordance with the MDR.

Based upon an estimate presented by notified bodies to the Medical Device Coordination Group (MDCG) on the 17th of November 2022, the number of certificates issued by May 2024 may only reach around 7,000 if the current rate of certificate issuance remains the same with no changes to current conditions in stark contrast to the near 25,000 valid certificates issued under the AIMDD and MDD that will expire before the 26th of May 2024.

Faced with this significant shortfall in capacity, it seems inevitable that the European Commission had to act to maintain the supply of medical devices into the EU market. The deletion of the ‘sell-off’ deadline will further ensure that safe and effective devices remain available beyond the
arbitrary date applied.