June “In All Other News”: MDCG Q&A on the AI Act, New MDSAP Website, MIR Form Updates & More
3 July 2025
UK Updates: International Reliance, IVDs, UDI, and Possible Indefinite Recognition of CE Marking
25 July 2025Background
The European Commission is progressing to make EUDAMED modules mandatory in phases, instead of waiting for all six to be complete. This approach became possible after amendments to the MDR and IVDR (Regulation (EU) 2024/1860).
Which modules will be first?
The initial rollout will include four modules:
- Actor Registration
- UDI/Device
- Notified Bodies & Certificates
- Market Surveillance
The Vigilance and Clinical Investigation modules will follow later.
What are the steps before mandatory use?
For EUDAMED to become mandatory, the following steps must occur:
- Each module must pass an independent audit and be confirmed fully functional.
- Notice of its mandatory use will be published in the Official Journal of the EU (OJEU).
- Six months after publication in the OJEU, use of the module will become mandatory.
- Regarding the Actor & UDI/Device modules: After the six-month transition following OJEU publication, manufacturers will have an additional twelve (12) months to enter all required data for devices already on the market. This applies to both legacy devices and devices placed on the market in accordance with the MDR/IVDR.
- Note that these modules are currently available for voluntary use. Therefore, you do not have to wait until OJEU publication to start entering your data. In fact, it is advisable to start the process early, as the system will likely become overloaded by manufacturers entering their data only after the mandatory use date nears.
EUDAMED Working Group Update
Timing to Publish in OJEU
In brief: the four EUDAMED modules are currently on track for Q3 publication in the OJEU. Further details below.
Much of the Commission’s timelines this past year (for example, the May 2025 Stuttgart workshop and MDCG 2024-11 Q&A) used a theoretical July 2025 OJEU publication date in their sample timelines. However, the most recent Working Group materials refer more generically to ‘Q3 2025,’ suggesting this could extend further into the quarter.
The MDCG Working Group’s 26 June 2025 presentation notes that the recent EUDAMED audit was largely successful. The audit report was circulated before the meeting, and if the Commission’s assessment of it is positive, it will launch a written confirmation of its mandatory use. It would then be published in the OJEU.
The targeted timeline for publication is noted as Q3 2025, making mandatory use start in Q1 2026. (See images below.)
This remains consistent with the Q2/Q3 target for OJEU publication in the December 2024 EUDAMED roadmap, though it is now toward the later end of that range.
What does this mean for manufacturers?
If your company markets medical devices or IVDs in the EU, you should prepare for mandatory EUDAMED use starting early 2026:
- Ensure you have an active Actor registration (SRN).
- Plan to complete UDI/Device entries for all your devices. This applies to both Regulation and Legacy devices.
In Summary
- The audit results are highly positive, but a final Commission decision is pending.
- The OJEU publication date is within a broader Q3 window.
- EUDAMED’s first four modules are on track for mandatory use in Q1 2026.
EUDAMED 2025 Workshops
To help economic operators and other users prepare, the Commission has scheduled hybrid workshops:
- 8 October 2025 (Rome, Italy)
- 3 December 2025 (Brussels, Belgium)
The workshops are hybrid, meaning they include both in-person and virtual attendance. However, the time zone is optimal for EU-based attendees.
Registration for these sessions is expected to open starting on 18 August 2025. For updates, check the Commission website, or check our Regulatory Updates page. We will post the registration link, once published.
