NEW – Important Document from the Medical Device Coordination Group (MDCG)
The Medical Device Coordination Group (MDCG) have just issued a new important document:
This is not a European Commission document, but the MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission and this clear warning to manufacturers should be heeded.
- The first adoption of MDR 2017/745 (fully applicable 26th May 2021) and IVDR 2017/746 (fully applicable 26th May 2022) was 5 years ago and some of the framework is still to be implemented.
- This notice (published 2 days ago) highlights some very significant problems and the medical device industry is moving to a higher alert level.
- Data collected by notified bodies, and presented to competent authorities in December 2021, shows that nearly 37% of manufacturers’ applications [under the Regulations] have been refused on the basis of incomplete applications, underlining an overall lack of manufacturers’ preparedness.
- In April 2022, 75% of notified bodies indicated that more than 50% of the submitted applications were deemed incomplete and more than 90% of currently valid AIMDD/MDD certificates will expire in 2023-2024.
- To date, 30 notified bodies are designated under the MDR, managing around 80% of current (expiring) AIMDD/MDD certificates.
- Manufacturers should take into consideration that it might not be possible that notified bodies designated under the MDR would be able to assess all corresponding files within the first months of 2024 (therefore significant bottlenecks should be expected in the run up to the final transition deadline).
- From 27 May 2024, the MDR will be fully applicable to all medical devices. From that date, medical devices not certified under the MDR will have no access to the EU market (so we may anticipate a profound shortage of medical devices for patients).
Note that none of this considers new devices, tech and new company submissions.
“Derogation from the conformity assessment procedure in accordance with Article 59 of the MDR has been mentioned as a possible remedy in case transition from AIMDD/MDD to MDR is not completed in time. It is important to stress that derogations may be granted by competent authorities only if the use of the device concerned is in the interest of public health, patient safety or patient health. This mechanism should not be considered as a solution for cases of late application to a notified body for conformity assessment or delays in the conformity assessment procedure.”
“In order to ensure that devices can continue to be placed on the market and to avoid shortages of medical devices, it is essential that all manufacturers adjust their system, finalise transition to the MDR and apply to a notified body, submitting complete and compliant applications, as soon as possible and well in advance of the end of the transition period to ensure timely compliance with the MDR.”
- Competent Authorities are unlikely to use Article 59 unless they perceive a significant risk to public health.
- The responsibilities have been placed firmly with medical device manufacturers as co-owners of the problem and this is a clear instruction to get all houses in order, asap. A lack of understanding or preparedness is not going to be accepted.
- Manufacturers and stakeholders have been warning that bottlenecks are not of their making, may not be within their control and may result in medical device shortages. So, some ripples and echoes of a ‘lack of understanding and empathy’ are moving through areas of medical device industry right now. Pragmatism and cooperation are going to be key in this period of difficulties.
- Medical Device Coordination Group (MDCG) new document - June 16, 2022
- New guidance on borderline between medical devices and medicinal products - April 27, 2022
- Cosmetic Product Regulation - March 30, 2022