Swissmedic Inspects Swiss Medical Device & IVD Importers
October 19, 2023
MDCG 2023-4: Guidance on Medical Device Software – Hardware Combinations
October 23, 2023Please read our April 25, 2024 post for the most current information.
EUDAMED will now likely become mandatory sometime toward the end of 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
The Update
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:
- All six modules will not be ready to undergo an independent audit until Q4 2026
- The hold-up is for the Clinical Investigation & Performance Studies module, which is not expected to be “audit-ready” until Q3 2026
- The audit is expected to be successfully concluded by Q2 2027
- After the successful audit, use of EUDAMED will be published in the Official Journal of the EU (OJEU)
- Then, the transition periods commence:
- Six months for the Actor, Vigilance, Market Surveillance, and Clinical Investigation & Performance Studies, i.e., mandatory in Q4 2027
- 24 months for the UDI/Device Registration and Notified Body & Certificates, i.e., mandatory in Q2 2029
Until EUDAMED is Mandatory
ntil 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.
Additional Resources
Related to general registration and timing:
Related to voluntarily registering in EUDAMED:
