Proposal for an extension of transition times for the EU MDR

After the MDCG 2022-14 position paper with 19 proposed solutions to the certification crisis for medical devices received a poor reception (see Has the MDCG found the answer to the slow rate of MDR certifications?), they have given further thought to steps that might help to resolve the increasing number of devices without a notified body certificates and which are therefore not able to be placed on the market.

After months of discussion including the MDCG, the Council Working Party for pharmaceuticals and medical devices, notified bodies and representations from Member States, the Commission is finally considering an extension to transition periods.

A proposal (so not yet final form) is being put to the EPSCO Health Counsel on 9 December which includes the following extended transition period dates for placing on the market of devices regulated under the directives:

While the proposal refers to extensions of both the MDR and IVDR, the suggested transition period extensions only refer to the MDR.

Certificate extensions

The proposal says that "if needed for legal and practical reasons", the extension could be combined with an extension of the validity of certificates under the MDD and the AIMD.

Obviously, an extension of the transitional periods without extending validity of certificates is not going to be helpful at all.  Without an extension of the validity of their certificates, companies still waiting for certificates will need to apply for derogations when their certificates expire and if derogations are not obtained, the devices will have to cease to be placed on the market.

The proposal suggests that manufacturers must also have "launched" the certification process.  It says that the application for conformity assessment must be submitted and/or accepted before a certain deadline (eg 26 May 2024).  Companies will want clarity on the  "and/or" in the statement.  More than 50% of applications to notified bodies have been refused for being incomplete, meaning that if acceptance by the notified body is a requirement, as opposed to an alternative, only half of companies making applications at any given time will be able to take advantage of the extension.  It is disappointing that after so many months of discussion this proposal is not more coherent.

It looks likely therefore that derogation applications are still going to part of the landscape for regulatory compliance in the EU for the foreseeable future.

We will await the outcome of the EPSCP Health Council on 9 December 2022 and a proposal for amending legislation, which could of course be different from that set out in the Note from the General Secretariat of the Council discussed above.  Fingers crossed.