New proposal to speed up the MDR certification process


Despite considerable efforts by the European Commission and the MDCG, there is growing concern about manufacturers' preparedness for the MDR transition. With less than two years to go until the mandatory application of the MDR, around 24,000 certificates will expire. In June, the MDCG issued a position paper (MDCG 2022-11) in which it stated:

"Data collected by Notified Bodies and submitted to the Authority in December 2021 currently show that nearly 37% of manufacturers' applications have been rejected due to incomplete applications, indicating a general lack of preparedness of manufacturers. In April 2022, 75% of Notified Bodies indicated that more than 50% of the applications submitted were considered incomplete."

Then, at the end of July, COCIR, which represents medical device manufacturers in the medical imaging, radiotherapy and digital health sectors, issued a proposal. The document contains proposals to speed up the MDR certification process. COCIR considers that concerns remain in the following areas:

  • Delays in audit timing and implementation.
  • The length of the review of the technical documentation and the time for issuing the certificate after a successful review.
  • Capacity limit for Notified Bodies.
  • Different interpretation and level of control within the same Notified Body between different auditors.

COCIR proposes in particular the followings:

  • Extending the use of online audit to all devices in general.
  • Use Medical Device Single Audit Program (MDSP) reports to increase efficiency.
  • Giving Notified Bodies more flexibility in determining the sampling of technical documentation.
  • Provide guidance on the use of performance data and make the interpretation of equivalence practical and flexible (as far as possible within the legal framework).

Among the detailed proposals, we would like to highlight one: the proposal states that the clinical evaluation requirements for MDR are the most complex in the world (!) and that MDR has brought a number of innovations in this area. However, the MEDDEV 2.7/1 rev4. guide has not been updated. By issuing an updated and complete clinical evaluation guideline, according to the MDR, many problems could be avoided when reviewing clinical evaluations.

I look forward to seeing what happens, whether the proposals will reach the decision-makers and whether we will see something in practice.