MDCG 2021-13 - EUDAMED Registration Q&A 📢

The #MDCG has just released a Q&A on the rules and obligations for registration in #EUDAMED for actors other than manufacturers, authorized representatives, and importers. These are for actors subject to the obligations of Article 28 (IVDR) and Article 31 (MDR), and clarifies the cases where, instead of a SRN, and Actor ID is issued.

☑  Actor ID : identifier issued to all actors registered in EUDAMED for their identification in the system.

☑  SRN: Single Registration Number that is issued through EUDAMED to manufacturers, authorised representatives and importers

Key Questions include:

-          What is the procedure to register as actor in EUDAMED?

-          Do manufacturers of only legacy devices have to register as actors in EUDAMED?

-          Do system and procedure pack producers (SPPP) have to register as actors in EUDAMED?

-          Do manufacturers of only custom-made devices have to register as actors in EUDAMED?

🔗 https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021-13_q-a-actor_registr_eudamed_en.pdf

#MDRG #MDRGuide #IVDR #MDR #Medicaldevices #EC