- Mandatory use of the first four EUDAMED modules (Actor registration, UDI/Devices registration, Notified Bodies & Certificates, and Market Surveillance) starts as of 28 May 2026
- EUDAMED PLG v3.22 released on 12 December: This release includes updates reflecting feedback from the VGL CA Board’s coordinated testing. According to the release notes, it is now possible to change the referenced device in a follow-up MIR, and the countries affected by an FSN will be automatically populated from the referenced FSCA report (as read-only). The Commission has invited feedback on this version by the end of January, latest mid-February, and we encourage you to test the new functionalities at your convenience.
Vigilance module audit:
The European Commission is aiming to initiate an audit of the Vigilance module by the end of Q1 2026, running until Q3 2026. Following completion, the Commission will be able to inform the MDCG of the audit conclusions (a prerequisite for Official Journal publication and subsequent mandatory use). Mandatory use of the VGL module is currently foreseen to start in Q1 2027.
The VGL CA Board did not conduct coordinated testing during 2025 but plans for the final coordinated testing exercise to help ensure the VGL module is sufficiently ready for mandatory use.
