The Medical Device Coordination Group (MDCG) has issued a Q&A on obligations and related rules for registration in EUDAMED of actors other than manufacturers, Authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR. It also clarifies the cases where an Actor ID is issued instead of an Single Regstration Number (SRN).
The six page document MDCG 2021-13 is entitled Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR.
The following questions are addressed in this document:
- What is the procedure to register as actor in EUDAMED?
- Do manufacturers of only custom-made devices have to register as actors in EUDAMED?
- When do manufacturers of only custom-made devices have to register as actors in EUDAMED?
- Do manufacturers of only legacy devices have to register as actors in EUDAMED?
- Do manufacturers of only ‘old’ devices have to register as actors in EUDAMED?
- Do system and procedure pack producers (SPPP) have to register as actors in EUDAMED?
- Who is the authority responsible for the approval of actor registration requests of SPPP located in non-EU countries?
- When the Actor ID may be considered as a Single Registration Number (SRN) pursuant to Article 31 MDR and Article 28 IVDR?
Source: Europa website