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 – August 2020.

24 Nov 2020 | MDCG

 

Theme EUDAMED
Target audience Manufacturers, Importers, Authorised representatives, Persons as referred to in Article 22 (systems and procedure packs)
Products concerned MD, IVD
 

 

 

Regulatory references

 MDR (EU) 2017/745

Article 30(1)

Article 31(2)

Article 33

 

IVDR (EU) 2017/746

Article 27 (1)

Article 28 (1)

Article 30

 

 

 

This MDCG position paper provides an update of the on the release of EUDAMED by tracing the history of information published by the European Commission so far.

EUDAMED database will be fully functional in May 2022, nevertheless the different modules will be made available to Member States on a gradual basis as soon as they become operational. In addition, the actor registration module will be accessible from 1 December 2020 so that actors can obtain their single registration number (SRN).