The European Union has confirmed that key modules of the EUDAMED (European Database on Medical Devices) system became mandatory on 28 May 2026, marking a major shift in medical device regulation across Europe.
What Happened
The EU now requires manufacturers and authorized representatives to use EUDAMED for regulatory submissions, replacing fragmented national systems with a centralized database. This improves transparency and traceability of medical devices across the EU market under both MDR and IVDR frameworks.
Key Dates & Timeline
- Mandatory date: 28 May 2026 ✓
- Transition period: 2024–2026 phased rollout (now concluded)
- Full enforcement: From mandatory activation date onward
- Post-implementation: Continuous regulatory reporting via EUDAMED
Required Actions
- Register devices in EUDAMED
- Submit safety and vigilance reports digitally
- Maintain updated manufacturer records
- Use centralized EU compliance tracking
Who Is Affected
- Medical device manufacturers
- Importers and distributors
- Notified bodies
- Healthcare regulatory teams
What Companies Should Do
- Ensure EUDAMED registration readiness — immediately if not already done
- Validate product data accuracy in the system
- Train regulatory teams on system usage
- Align internal reporting systems with EUDAMED requirements
EUDAMED is now mandatory, centralizing EU medical device compliance and significantly increasing digital reporting obligations for all manufacturers and authorized representatives.
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