Mandatory EUDAMED modules · operational service
EUDAMED device registration, from actor data to UDI records.
MEDDEV defines the registration scope, prepares actor and device data, supports the SRN process and enters approved records for the responsible economic operator.
Defined registration work
One sequence, with responsibilities left where the law puts them.
The manufacturer assigns UDI identifiers and remains responsible for data accuracy. MEDDEV organises the data, identifies missing links and executes entries from information approved by the responsible operator.
01Economic-operator role and actor-registration request
02SRN support and competent-authority follow-up
03Basic UDI-DI, UDI-DI and device data preparation
04Links to the EU representative, importer and certificates
05Registration record and update responsibilities
Official basis checked on 27 July 2026
The European Commission states that the first four EUDAMED modules became mandatory on 28 May 2026. Regulation (EU) 2024/1860 provides the modular implementation and transitional framework.
European Commission: EUDAMED overview → · Regulation (EU) 2024/1860 →