European Commission publishes EUDAMED Release Notes v2.25.2
The European Commission has published EUDAMED Release Notes v2.25.2, introducing new system functionalities and tighter validation controls across key modules.
This update continues the transition toward a more controlled, transparent, and data-driven regulatory environment, with direct implications for manufacturers—particularly in certificate management and data governance.
Actor Module
A new notification mechanism has been introduced: non-EU manufacturers will now be automatically informed when their Authorised Representative changes Competent Authority.
At the same time, PRRC data is no longer visible for inactive or historical actors, reinforcing GDPR compliance and limiting access to supervisory authorities only.
Certificates Module
EUDAMED expands functionality by allowing Notified Bodies to reference unregistered manufacturers (including non-EU) in refused or withdrawn certificates.
Additionally, the system now displays the registration (last update) date for these records.
More significantly, new validation rules have been implemented:
IVDR certificates are now restricted to Classes B, C, and D under defined conditions
Certificate combinations are validated against the conformity assessment route
QMS and Technical Documentation certificates must be issued by the same Notified Body
Certificates are only considered valid if active and within their validity period
Certificate registration has also become more flexible, allowing initial entries with non-“Issued” statuses (e.g. amended, supplemented, re-issued) and enabling references to certificates not yet registered in EUDAMED.
DTX Module & Public Access
Authorities and manufacturers can now download discarded device data via API, improving access to full lifecycle information.
In parallel, a new Public API (JSON) enables structured access to Actor and Device data, supporting digital integration and automation.
What this means for manufacturers
This release reinforces a clear direction:
Stronger validation of regulatory data
Greater alignment between certificates and conformity routes
Increased transparency and system interoperability
Manufacturers should review their EUDAMED submissions, certificate strategies, and data structures to ensure consistency with the new system rules.
Read the full document below.
