The Medical Device Coordination Group (MDCG) released a new Position Paper today:
MDCG 2022-11 – Notice to manufacturers to ensure timely compliance with MDR requirements
If you have not yet started the process to transition your ‘legacy’ devices from the MDD/AIMDD to the MDR, you should do so immediately.
No additional transition period will be granted. If your device is not MDR CE marked by 27 May 2024, it may no longer be placed onto the European Single Market: EU-27, Iceland, Liechtenstein, Norway, Northern Ireland, and Turkey.
Further, the MDCG guidance warns:
Due to the high number of certificates expiring in 2023 and 2024, Notified Bodies may not be able to assess all files within the first months of 2024. Data indicates that 90% of all active AIMDD/MDD CE marking certificates will expire in that 1.5-year period, with 70% expiring in the six-month period of 2024.
NOTE: the above data does not account for MDD Class I self-certified legacy devices, which have been up-classed under the MDR, such as Class I reusable surgical instruments and some software and some substance based devices. These devices must also obtain MDR CE marking certification by 27 May 2024, adding to the Notified Body workload.