The European Proposal to Delay Compliance for Legacy IVDs and EUDAMED Rollout

By Klarizza Pacris, Annette van Raamsdonk and Evangeline Loh

The European Commission (EC) has made a proposal (COM(2024)43/ 5712/24) to delay compliance of legacy IVD devices and for EUDAMED to be rolled out by modules completed.

The proposal would extend the time for manufacturers of legacy IVDs to become compliant with the IVDR. Also,  analogous to Regulation (EU) 2023/607, requires an application with a notified body designated for the IVDR and an agreement with the notified body covering the devices in question, two years before the deadline May 26 and September 26, respectively. In addition, modules of EUDAMED could be rolled out, with the first set expected in Q4 2025. Economic operators are required to notify competent authorities in the event they expect shortages of their devices.

Furthermore, the EC submitted the proposal to the Council and European Parliament for the first reading.

Council Working Party on pharmaceuticals and medical devices

The Working Party on Pharmaceuticals and Medical Devices of the Council convened (January 30) to discuss the proposal and it was reported  (Document ST_6067_2024_INIT) that the “delegations intervening suggested no modifications to the text proposed by the Commission”. It was concluded that the proposal be supported “without amendments”.

It was recommended that the EC proposal serve as the basis for negotiations with the European Parliament.

How do you track the progress of the proposal?

The EC proposal has been assigned Procedure 2024/0021/COD, and can be tracked here.

What is next?

As part of this first reading, the proposal is now with the European Parliament. During the last Medical Device Coordination Group (MDCG) meeting (February 6), stakeholders raised several concerns, which it was felt would need to be better described in the current proposed amendment, such as the notification requirement in case of shortages. While it is not expected that the process will be protracted, there may be additional readings. However as soon as it is approved, it will be published in the Official Journal of the European Union (OJEU), and the regulation will enter into force and amend the IVDR and MDR.

Concluding remarks

The EC proposal is with the European Parliament. While it is clear from its documents that the Council appears to be advancing the EC proposal as drafted, based on stakeholder comments, revisions may be required.

Emergo by UL will continue to monitor developments with the EC proposal.