MDCG 2021-13 Rev. 1 : 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 – June 2021

This document provides information on the obligations and modalities of registration in the actor module of EUDAMED for operators other than manufacturers, authorised representatives and importers and on the use of the Actor ID as the SRN for this registration. It is addressed specifically to manufacturers of custom-made devices only, manufacturers of legacy devices only, manufacturers of ‘old’ devices as well as to system and procedure pack producers (SPPP).