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.
The European Proposal to Delay Compliance for Legacy IVDs and EUDAMED Rollout | Emergo by UL
The European Proposal to Delay Compliance for Legacy IVDs and EUDAMED Rollout
The EC proposed a delay to compliance of legacy IVDs and for EUDAMED to be phased in.
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