EUDAMED Registration

EUDAMED Registration

The EUDAMED Actors module is all set to start accepting registrations from member states and economic operators from 1st December 2020.  EUDAMED is a portal that consists of 6 modules and the Actors module serves as the establishment registration portal in the EU.1

Any organization who performs the following roles must register in the actors module and obtain a Single Registration Number (SRN):1

  • Commissions
  • Competent authority (CA)
  • Designating Authority (DA)
  • Notified Bodies (NB)
  • Manufacturers (MF)
  • Authorized Representative (AR)
  • System and Procedure Pack Producer (PR)
  • Importer (IM)

Distributors do not have to be registered in the EUDAMED.1

After registration, the economic operators will be approved by a competent authority and will be granted an SRN. The SRN uniquely identifies every economic operator and a new SRN must be obtained for each role of the organization. E.g. an organization which is a manufacturer as well as an importer must obtain two SRNs for each of its operations.1

For non-EU manufacturers, their authorized representative must verify their registration request before it is submitted to the competent authority for approval. To process the registration, all registrants must submit a signed declaration of information security responsibilities, and non-EU manufacturers must also submit a mandate summary document and must have an active authorized representative.1 While operators are not required to register immediately, you must register in the actors module before you can access the device module which is set to release in May 2021.1

Need help with EU MDR? Call us today at +1 249-987-4497 or email us at info@emmainternational.com to know more about how we can help.


1EU Commission (2020) Actor Roles and Actor Registration Process retrieved on 10/29/2020 from https://ec.europa.eu/health/md_eudamed/actors_registration_en

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