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.