Breaking Down the EU’s Latest EUDAMED Functional Confirmation

On 2025-Nov-27, the European Commission published a EUDAMED Functional Notice
in the Official Journal of the European Union (OJEU) announcing that several major EUDAMED modules:

• Actors Registration
• UDI/Devices
• Notified Bodies & Certificates
• Market Surveillance

“have achieved functionality and meet the functional specifications.”

This notice marks a significant milestone toward full EUDAMED implementation. It also signals that manufacturers should intensify their preparations for data readiness, system integration, and upcoming submission timelines.

In This On-Demand Webinar, You Will Learn:

• What this Functional Notice means in practice
• How it impacts device manufacturers
• What actions organizations should prioritize now
• How to assess data readiness for the live modules
• What still remains to be finalized by the Commission

Why It Matters Now

EUDAMED readiness has reached a new stage. On November 27, 2025, the European Commission formally confirmed in the OJEU that the Actors, UDI/Devices, Notified Bodies/Certificates, and Market Surveillance modules meet the required specifications.

This notice accelerates expectations for manufacturers. Therefore, organizations must ensure their device data is complete, consistent, and ready for submission once final timelines are confirmed. In this session, we explain what this update means for your regulatory strategy and how to prepare your systems and processes for the next phase of EUDAMED activation.