Distributors and importers: new MDCG Q&A

The MDCG has published a new Q&A document with the aim to provide more details on the implementation of Articles 13 and 14 and other related obligations for importers and distributors under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

The Q&A addresses the following topics:

  • Distinguishing importers and distributors;
  • General Obligations;
  • Verification Obligations;
  • Registration Obligations;
  • Other.

It also gives practical examples on: