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;
It also gives practical examples on:
- How to determine the importer when the . . .
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