Guidance on when EU importers and distributors become manufacturers published

The EC Medical Device Coordination Group (MDCG) has published a new guidance clarifying the requirements of Article 16 of the Medical Device Regulation (MDR, 2017/745) and In Vitro Diagnostic Regulation (IVDR, 2017/746) relating to the circumstances under which EU importers and distributors of medical devices may be regulated as manufacturers.

The guidance, MDCG 2021-26, ‘Questions and Answers on repackaging & relabeling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746’, is available from here.