EUDAMED 2026
EUDAMED Registration and Regulatory Data Readiness
Prepare structured actor and device information before regulatory submission.
Mandatory modules
Actor Registration, UDI/Device Registration, Notified Bodies & Certificates and Market Surveillance became mandatory EUDAMED modules on 28 May 2026.
Actor registration
The Actor Registration module supports the information required to obtain an Actor ID / Single Registration Number for economic operators.
UDI / Device information
Manufacturers are required to maintain structured UDI and device information for devices placed on the EU market.
Data preparation areas
- Legal manufacturer information.
- Economic-operator role.
- EU representative information where applicable.
- Basic UDI-DI and UDI-DI.
- Device nomenclature and classification.
- Certificate references where applicable.