EUDAMED

1. The 6 Modules of Eudamed

• (1) Actor Registration
• (2) UDI/Device Registration
• (3) Notified Body and Certificates
• (4) Clinical Investigations and Performance Studies
• (5) Market Surveillance and Post-Market Surveillance (PMS)
• (6) Vigilance

2. Eudamed Gradual Implementation Roadmap

• The European Commission, in agreement with the MDCG, decided to implement each module of Eudamed progressively.
• (1) The first module to be implemented was the Actor Registration Module, which became operational on December 1, 2020 (European standard).
• (2) The second module, UDI/Device Registration, and the third module, Certificates and Notified Bodies (NB), are scheduled for implementation in May 2021.

3. Actor Registration Module

What is an Actor?
According to the guidance, Actors include the Economic Operators defined under the MDR (manufacturers, authorized representatives, importers, distributors, and system/procedure pack actors), as well as the Commission, Competent Authorities (CA), Designating Authorities (DA), and Notified Bodies (NB).

The Actor Registration Module serves two primary functions:

1. – Registration of all Actors mentioned above.
2. – Issuance of the Single Registration Number (SRN).

Wise Company offers Actor Registration and SRN (Single Registration Number) issuance services.