A major milestone has now been reached for EUDAMED – and this one has real regulatory consequences. Following the publication of Commission Decision (EU) 2025/2371 in the Official Journal of the European Union on 27 November 2025, the European Commission confirmed that the first four EUDAMED modules are fully functional and meet their required specifications. Under the transitional provisions in Regulation (EU) 2024/1860, that publication triggered a six-month transition period. From 28 May 2026, use of those four modules becomes mandatory.
Need help getting ready for mandatory EUDAMED use?
Which modules become mandatory from 28 May 2026?
- Actor registration
- UDI/Devices registration
- Notified Bodies and Certificates
- Market Surveillance
This is the first time a defined group of EUDAMED modules moves from voluntary use to mandatory legal use under the MDR and IVDR framework. In plain English, EUDAMED is finally leaving its long-running soft-launch era behind.
Why this matters in practice
For many organisations, EUDAMED has already been a challenge. Data readiness, data migration, system integration, role allocation, and usability issues have all slowed progress. The problem is that these headaches do not magically disappear just because the deadline has become official.
What changes from May 2026 is visibility. Data that has been sitting in spreadsheets, disconnected systems, or someone’s overworked regulatory to-do list now needs to be structured, validated, and submitted correctly. That affects not only regulatory teams, but also quality, supply chain, labelling, and post-market functions.
For non-EU manufacturers, the timing also reinforces the importance of working with a competent EU Authorised Representative, especially where actor registration, device registration, and ongoing communication with authorities need to run smoothly.
The Commission is offering training - and it is worth paying attention
In a welcome step, the European Commission has scheduled a series of full-day, web-streamed EUDAMED training sessions:
- Actor module – 28 April 2026 | 09:00-18:00 CEST
- UDI/Devices module – 5 May 2026 | 09:00-18:00 CEST
- Notified Bodies and Certificates module – 7 May 2026 | 09:00-18:00 CEST
Training materials are also available through the EUDAMED Information Centre. These sessions should help regulatory teams understand both the practical workflow and the Commission’s expectations.
That said, training is support – not a substitute for preparation. Watching a webcast is useful. It is not the same thing as fixing poor master data, clarifying internal ownership, or testing whether your UDI records actually line up with your technical documentation. Bureaucracy, as ever, remains unimpressed by good intentions.
What organisations should be doing now
1. Confirm actor registration status
Make sure the correct legal entity is registered and that the right users, roles, and permissions are in place.
2. Review UDI and device data
Before registration, ensure your UDI system is fully established and reliable. If your UDI processes are inconsistent, fragmented, or spread across multiple systems, they should be addressed now. Device data must be accurate and complete before it is submitted, as it will be visible and relied upon by regulators and stakeholders.
3. Check certificate data pathways
Manufacturers should ensure they understand how certificate-related information will flow between Notified Bodies, internal teams, and EUDAMED.
4. Strengthen market surveillance inputs
If your PMS processes are shaky, EUDAMED will not hide that for long. Build a stronger framework before the deadline becomes painful.
5. Test internal responsibilities
Regulatory, quality, supply chain, and commercial teams need to be aligned on who owns what. EUDAMED is not just a regulatory affairs admin task.
Final thoughts
These training sessions are a positive and necessary move from the Commission. They should help reduce confusion and support more consistent adoption across the industry.
But the organisations that handle this best will not be the ones who simply attend a training day and hope for the best. They will be the ones that use the next few weeks to tighten internal processes, improve data governance, and resolve practical blockers before mandatory use begins.
At Patient Guard, we have seen first-hand where organisations tend to struggle with EUDAMED – from actor registration and UDI submissions through to wider MDR implementation and ongoing data management. That is why early preparation matters. By the time a system becomes mandatory, the margin for avoidable mistakes is usually very small. Explore MDR for Beginners, Medical Device UDI for Beginners, or Post Market Surveillance support for related guidance and services.
Vigilance reporting requirements under MDR
EUDAMED is entering a new phase, and the countdown is no longer theoretical. From 28 May 2026, four core modules become mandatory, and that raises the bar for regulatory readiness across the sector.
The businesses that treat this as a strategic transition – not just an admin task – will be in a far stronger position. Those that leave it too late may discover that EUDAMED is excellent at exposing messy data, weak ownership, and compliance gaps they thought they still had time to ignore.
If your team needs support with EUDAMED preparation, EU Authorised Representative services, or broader MDR readiness, contact Patient Guard to speak with a regulatory expert.
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