There has been an update. Please read our 23 January 2024 post for the most current information: EU Commission proposes a “gradual roll-out” of EUDAMED, starting in 2025
As Casus originally reported on 28 August 2023, the EU Commission had removed the EUDAMED timeline from the website. Further, based on the most recent EUDAMED Working Group meeting minutes, EUDAMED appeared to be further postponed.
The EU Commission has now officially confirmed the delay by posting a new draft EUDAMED timeline to its website, available: HERE
Based on the updated timeline, it does not appear that EUDAMED will be deemed fully functional until at least Q2 2027, followed by the transition period.
The new draft timeline indicates that:
Until the above steps occur, EUDAMED is voluntary. Instead, the registration requirements outlined in the old Directives (MDD/AIMDD/IVDD) continue to prevail.
That said, please note that some Competent Authorities are already making some parts of EUDAMED compulsory. For example, the Irish Competent Authority requests that Class I medical device and IVD notifications be conducted in EUDAMED instead of directly to them. So even though EUDAMED is voluntary per the MDR/IVDR, the best practice is to verify requirements with your individual Competent Authority.
Related to general registration and timing:
Related to voluntarily registering in EUDAMED:
