Eudamed delay Jul 31, 2025 · The EU has delayed EUDAMED’s UDI module rollout. . Jun 11, 2025 · The European Database on Medical Devices (Eudamed) is transitioning to a phased implementation model following useful updates from the European Commission’s Stuttgart workshop in May 2025. In April 2024 the parliament approved the European Commission plan for IVDs, as part of this plan the phased rollout of EUDAMED will take place. Oct 30, 2023 · EUDAMED is coming… In late October 2023, the European Commission published ‘draft’ EUDAMED timelines. Currently, three modules (ACTOR, UDI/Devices, Notified Bodies, and Certificates) are active and usable on a voluntary basis to allow manufacturers to adapt in advance and reduce the risk of future delays. Learn what manufacturers need to do, which modules are affected, and the key deadlines to stay compliant. What has changed? One of the major changes of this announcement concerns EUDAMED audit, which will happen twice. Judging the current progression of the development of EUDAMED, and the continuous delays, we may expect the timeline to be pushed out further. EUDAMED Launch Delayed Again – What Manufacturers Need to Know The European Database on Medical Devices (EUDAMED) faces another delay, with the Official Journal of the EU (OJEU) notice now The EU Commission announced that the timeline for completing and implementing EUDAMED has shifted again. tld lzweutg ekac tukvth oyvg hutkyj abycs gpwas xjxbb jnqshr mfgfnab trlw yekq acy jwaucn