Revised Q&A on registration of “other” actors in EUDAMED

The Medical Device Coordination Group (MDCG) has just revised the MDCG 2021-13 Guidance published last June by adding a 9th question to the Q&A on the obligations and rules for the registration in EUDAMED of actors other than manufacturers, authorized representative and importers subject to the obligations of Article 31 of Regulation (EU) 2017/745 and Article 28 of Regulation (EU) 2017/746.

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

DOWNLOAD THE Q&A MDGC 2021-13 REV 1 : REGISTRATION OF “OTHER” ACTORS IN EUDAMED