MDCG 2021-13 rev.1

This Q&A is a document aimed at addressing questions relating to the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 of Regulation (EU) 2017/745 on medical devices (MDR) and/or Article 28 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). It also clarifies the cases where an Actor ID is issued instead of an SRN.

This document should be read in conjunction with other relevant MDCG Guidance documents.

You will find the MDCG 2021-13 rev. 1 here.