A manufacturer established outside the European Union cannot create an EUDAMED account in its own name. The database is accessible to actors registered in the EU. The registration of a non-EU manufacturer must necessarily go through its authorised representative (EC REP). This rule has concrete implications for how the relationship between the two parties is organised.
Why a non-EU manufacturer cannot register directly
The ACTOR module of EUDAMED requires an address in the European Union for the initial registration. A US, Japanese or Chinese manufacturer does not have such an address. It is the EC REP — established in the EU — that creates the account, carries out the registration formalities, and obtains the SRN (Single Registration Number) on behalf of the manufacturer.
This SRN is the manufacturer’s permanent identifier in EUDAMED. It is unique and does not change if the EC REP changes.
The allocation of roles in EUDAMED
The EC REP is responsible for: The creation and management of the manufacturer’s EUDAMED account. The registration of devices in the UDI/DEVICES module (description, class, conformity assessment procedure, notified body, associated certificate). Updating information when a change occurs. Managing vigilance obligations in the corresponding module.
The manufacturer is responsible for: Providing the EC REP with all the information needed for registration, within the deadlines set by the Regulation. The accuracy of the registered information: if the data provided by the manufacturer is incorrect, the responsibility lies with the manufacturer, even if it was the EC REP who performed the data entry.
The risks of poor coordination
EUDAMED can be consulted by the competent authorities of all Member States and, for certain data, by the public. Incorrect or outdated information in EUDAMED constitutes a regulatory non-conformity that may be identified during a market surveillance action.
The most frequent cases: a change of device reference not reflected in EUDAMED, an expired notified body certificate still shown as valid, or an outdated manufacturer address. These situations arise when communication between the manufacturer and its EC REP breaks down.
What the contract must provide for
The EC REP contract must define: the deadlines within which the manufacturer informs the EC REP of any change affecting EUDAMED data, the process for verifying the accuracy of the registered data, and the liability in the event of erroneous information. These clauses protect both parties.