The European Commission has released a revised timeline for the gradual rollout of the European Database on Medical Devices (EUDAMED), reflecting the current consultation status with the Medical Device Coordination Group (MDCG) and recent policy updates. This timeline clarifies key milestones for stakeholders and provides crucial visibility into when the different EUDAMED modules are expected to become mandatory.
The Key Highlights of the Updated Timeline can be seen below:
Q2–Q3 2025: The European Commission is expected to publish formal notices in the Official Journal of the European Union (OJEU) confirming the functionality of key EUDAMED modules, including:
- Actor registration
- UDI/Devices
- Notified Bodies & Certificates
- Market Surveillance
These notices will trigger the start of mandatory use of the relevant modules after a six-month period.
Onboarding Activities: From Q2 2025 onward, onboarding activities are being scaled up. Training materials are being made available to support economic operators, Notified Bodies, and competent authorities in the use of the declared functional modules.
Vigilance Module Still Pending: The Vigilance module remains under development, with its notice expected to be published in the OJEU in Q4 2025 or Q1 2026. Mandatory use of the Vigilance module will begin six months after its formal declaration of functionality.
End of Transition Periods: The transition period for device registration will conclude in Q3 2026, marking a critical compliance deadline for manufacturers.
Full EUDAMED Implementation Targeted for Early 2027: By Q1 2027, the full mandatory use of all EUDAMED modules, including the Vigilance module, is expected to be in effect.
Summary of Actions for Stakeholders:
- Stay alert for the OJEU notices that will start the six-month countdown to mandatory module use.
- Prepare for onboarding by reviewing available training materials and ensuring internal processes align with EUDAMED requirements.
- Monitor updates, as the timeline is subject to change pending MDCG consultations.
- For clients relying on our regulatory support services, we will continue to monitor the situation and provide timely updates to ensure compliance with all evolving EUDAMED obligations.
We would like to stress that this timeline has just been published and still currently under review.
The updated timeline which is under review can be seen below:
