Over the past few months, a member of the Advena Team has participated in several training sessions and workshops organized by the European Commission focusing on the implementation of EUDAMED — the European Database on Medical Devices. These sessions provided valuable insights into the system’s structure, functionality, and the upcoming regulatory requirements for economic operators.
According to the European Commission, the official publication of EUDAMED is expected by mid-November 2025. This means that the mandatory use of EUDAMED and associated registration obligations are planned to begin six months later, around mid-May 2026.
Manufacturers and other economic operators are strongly encouraged to familiarize themselves with the platform in advance. We recommend that all actors begin the registration process as early as possible and, at minimum, obtain their Actor ID (SRN).
In addition to the live EUDAMED environment, the EUDAMED Playground version is also available. This training environment offers users an opportunity to explore the system’s functionality and practice data entry before working on the live database.
The following modules are projected to become mandatory six months after publication within the OJEU;
- Actor registration
- UDI/Device registration (UDI-DI)
- Notified Bodies and Certificates
- Market Surveillance
Key Points on Device Registration
The Commission has provided additional clarification on the registration of both legacy and Regulation-compliant devices:
- All legacy and Regulation devices must be registered in EUDAMED.
- Legacy devices are exempt from registration only when an equivalent Regulation device (with the same UDI-DI, catalogue/reference number, or trade name) has already been registered.
- Devices no longer placed on the market at the time the EUDAMED modules become mandatory do not need to be registered, unless a vigilance issue arises.
A timeline that was shared during the event can be seen below:
How Advena Can Help
Navigating EUDAMED requirements can be complex. If you need support with device registration or assistance obtaining your Actor ID (SRN), the Advena Team is ready to guide you through the process and ensure your compliance with the upcoming obligations.
