New MDCG Guidance 2022-7: FAQs on the EU UDI System
10 June 2022
Transfer your EU Authorized Representative (EC Rep): Steps and Timing
22 June 2022
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
In short:
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.
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Expect a long MDR certification process. The Position Paper states that:
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- December 2021 – nearly 37% of manufacturers’ applications have been refused on the basis of incomplete applications, underlining an overall lack of manufacturers’ preparedness
- April 2022 – 75% of Notified Bodies indicated that more than 50% of the submitted applications were deemed incomplete
Do not count on exception mechanisms in the MDR to act as a safety net. Article 59 derogations from conformity assessment may be granted by Competent Authorities only in cases of public health, patient safety or patient health. Article 59 is not intended as an antidote for late MDR applications or delays in the MDR conformity assessment process.
As of today 30 notified bodies are designated under the MDR.
To best ensure you do not experience a sales gap in the European market, it is recommended to start the MDR CE marking process as soon as possible.
