As of December 01, 2020 the European Commission will make the Actor registration module available which will be the first of six EUDAMED modules.
Economic operators can submit information through the Actor registration module to obtain a single registration number (SRN). With the SRN, economic actors can be clearly identified throughout the EU (also outside EUDAMED). The SRN is generated and forwarded to the economic operator by EUDAMED after the request to the respective national competent authority. Every economic operator (EU and non-EU manufacturers, authorised representatives, system/procedure pack producers and importers) has to register as an actor in EUDAMED and provide the required information.
The following documentation needs to be submitted along with the actor’s registration request:
- Declaration on information security responsabilities (all actors, has to be signed and uploaded)
- Mandate Summary document (only for non-EU manufacturers, to register in EUDAMED, an authorised representative is mandatory)
When an actor is registered in EUDAMED with its first Local Actor Administrator (LAA) and has obtained an SRN, more users of this actor can request access to EUDAMED. The LAA is the highest profile and contains the grants/rights of all the lower users. The European Commission recommends to have at least 2 LAA to act as a fail safe mechanism if one should be unable to respond.