Bioexcelife
On 27 November 2025, the European Commission officially announced that four EUDAMED modules are now fully functional and will become mandatory for use on 28 May 2026. https://health.ec.europa.eu/latest-updates/eudamed-four-first-modules-will-be-mandatory-use-28-may-2026-2025-11-27_en
This change, published in Commission Decision (EU) 2025/2371, therefore marks a major turning point in EU MDR regulation, and it will greatly impact how manufacturers prepare for compliance moving forward.
If you place medical devices on the EU market, this update directly impacts you.
Which EUDAMED Modules Become Mandatory?
Starting 28 May 2026, the following modules must be used by all manufacturers, authorised representatives, importers, and notified bodies:
1. Actor Registration
Register as a manufacturer, authorised representative, importer, or any economic operator.
2. UDI / Device Registration
Upload UDI-DIs, UDI-PIs, and complete device master data for every device you market in the EU.
3. Notified Bodies & Certificates
Notified bodies must register issued CE certificates; manufacturers must ensure accuracy.
4. Market Surveillance
Competent authorities will enter inspections, vigilance follow-ups, and surveillance activities.
These four modules have passed the functional assessment and are now legally enforceable.
Why This Matters for Manufacturers
This update brings greater transparency across the EU device market. It will improve:
Traceability through UDI
Market oversight through surveillance
Consistency in certificate and device data
Accountability for all economic operators
More importantly:
👉 If your device or company is not properly registered in EUDAMED after May 2026…
Your EU market access may be at risk.
Key Dates You Must Know
| Event | Date |
|---|---|
| Commission Decision published | 27 Nov 2025 |
| Mandatory use of first 4 modules | 28 May 2026 |
This six-month window is the transition period — meaning 2025–2026 is your preparation time.
What Manufacturers Should Do Now
🔹 1. Complete Actor Registration
Every manufacturer, importer, and authorised representative must register early.
🔹 2. Prepare UDI Data
Ensure all devices have correct UDI-DI, UDI-PI, and device master data ready for upload.
🔹 3. Verify CE Certificates
Coordinate with your Notified Body to ensure certificates will be correctly registered.
🔹 4. Update PMS & Surveillance Procedures
Your post-market surveillance system should align with the new EUDAMED structure.
🔹 5. Clean Up Documentation
Make sure device descriptions, labels, IFUs, and technical files match the data you will upload.
What About the Remaining EUDAMED Modules?
The remaining modules — Vigilance and Clinical Investigations — will be introduced later. However, the mandatory rollout of the first four modules is the foundation that all manufacturers must comply with starting May 2026.
Conclusion: Your EUDAMED Prep Starts Now
The EU has made it clear:
EUDAMED is no longer optional.
With the first four modules becoming mandatory from 28 May 2026, manufacturers must act quickly to ensure compliance, avoid delays, and maintain EU market access.
This update isn’t just regulatory — it represents a shift toward a fully transparent, traceable, and harmonised European device ecosystem.
If your organisation sells or plans to sell devices in the EU, now is the time to prepare.
