What's EUDAMED like in 2025?

The European database on medical devices, EUDAMED, is a central element of the regulatory framework imposed by the MDR (EU 2017/745) and IVDR (EU 2017/746) regulations. It aims to strengthen the traceability, transparency, and market surveillance of medical devices and in vitro diagnostic devices within the European Union.

But concretely, in 2025, where are we in its deployment? And what are the current or upcoming obligations for manufacturers, authorized representatives, importers, and notified bodies? Here is a clear and up-to-date summary based on the latest official publications from the European Commission.

Reminder: what is EUDAMED?

EUDAMED is a public and interconnected database, structured into six distinct modules:

1. Registration of actors (manufacturers, authorized representatives, importers, etc.)
2. Registration of devices / UDI system
3. Certificates and notified bodies
4. Clinical investigations and performance studies
5. Vigilance
6. Market surveillance

Its objective is to centralize all regulatory data related to medical devices marketed in the EU, in order to facilitate transparency for the public and authorities, and to improve risk management throughout the lifecycle of devices.

Operational modules by the end of 2024: a regulatory turning point

According to the official timetable published by the European Commission (December 2024), four of the six modules have been audited and finalized by the end of 2024:

• Registration of economic operators
• Registration of devices (UDI)
• Registration of CE certificates and notified bodies
• Module of market surveillance

These four modules are now considered functional and will be subject to an official publication in the Official Journal of the European Union (OJEU) in 2025. This publication will trigger the regulatory obligation to use them within 6 months.

👉 It is therefore very likely that these modules will become mandatory in the second half of 2025.

Modules still under development

Two modules have not yet been finalized:

• The Vigilance module, dedicated to incidents and recalls, is currently under audit for implementation expected in 2026.
• The Clinical Investigations / Performance Studies module remains in the analysis and development phase, with no firm deadline.

Key deadlines to remember

Here is a summary of the main dates to know:

(Source : EUDAMED Gradual Roll-Out Planning – Commission européenne, décembre 2024)

Why anticipate the EUDAMED obligation?

Even if certain obligations are not yet active at the European level, several signals should prompt manufacturers to act now:

• National authorities, such as Ireland (HPRA), are already requesting voluntary registration on EUDAMED.
• Notified bodies frequently require the SRN (Single Registration Number) in MDR/IVDR files.
• The quality of UDI data conditions the responsiveness in the event of incidents, recalls, or regulatory updates.

Our practical recommendations

1. Register your actors now (manufacturers, AR, importers)
2. Prepare your UDI data in a structured format compliant with EUDAMED technical requirements
3. Train your RA/QA and IT teams on the functioning of the database
4. Monitor updates from the European Commission
5. Integrate EUDAMED into your overall regulatory strategy

Conclusion

The year 2025 marks a strategic milestone in the implementation of EUDAMED. Four modules are ready and about to become mandatory. Companies in the MedTech sector must organize themselves to integrate these requirements, not as an administrative burden, but as a lever for regulatory efficiency, transparency, and trust.

📧 Need support?

Contact us to discuss! Our team is here to answer your questions and support you in structuring your UDI data, anticipating audits, or training your teams.