Health · EU
EUDAMED
Medical device firms, devices and certificates must all be registered in EUDAMED, the EU's device database.
ForHeads of regulatory affairs at medical device makers and importers selling in the EU.
What’s changing, and when
The Commission confirmed four EUDAMED modules as functional on 27 November 2025, and their use became mandatory on 28 May 2026. Devices already on the market must be registered within 12 months of that notice, and notified bodies must enter certificate information within 18 months. Vigilance and clinical investigation modules follow later.
- May 2026 Four modules mandatory, including actor and device registration
- Nov 2026 Devices already on the market registered
- May 2027 Certificate information entered by notified bodies
Why it can’t happen in one step
Every device, variant and certificate has to be registered, and makers, importers and notified bodies each hold part of the record.
How Polymonial carries you across
- Device records that cannot be quietly changed.
- Share what authorities and notified bodies need, secure for them alone.
- Your device data stays current as the database's formats change.
Trust that travels.
Secure, trusted and under your control.