Medical Devices - EUDAMED

Actor registration module

  1. Deutsch
  2. English

On 1st December 2020 the European Commission has made available the Actor registration module.

It is the first of six EUDAMED modules.

FAQs

Single Registration Number – SRN

The Actor registration module enables economic operators to submit, by means of an actor registration request, the information necessary to obtain a single registration number (SRN).

The SRN guarantees a EU-wide unique identification for economic operators (also outside of EUDAMED).

  • Following the assessment and approval of the request by the concerned national competent authority, EUDAMED generates the SRN of the economic operator to the national competent authority and transfers it to the requesting economic operator.
    Infographic: Actor roles and SRN

Actor registration request process

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.

Documents to provide with the actor registration request

  1. Declaration on information security responsabilities
    All actors must upload a signed Declaration on information security responsibilities (template in all EU languages)
  2. Mandate Summary document
    To register in EUDAMED, the non-EU manufacturers must have an active authorised representative and submit with the registration a Mandate Summary document

EUDAMED registered users

For an actor already registered in EUDAMED, all persons who intend to act on behalf of this actor need to enter an access request.

User guide for Economic Operators

Guide to using EUDAMED – Actor registration module for Economic Operators

Technical documentation

Other useful information

  • MDCG 2020-15 MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States
  • Guidance documents to assist stakeholders in implementing the medical devices regulations.
Disclaimer:
The documentation in this page is subject to changes and updates whenever new information becomes available.