Medical device clinical investigations — What’s new under the MDR?

Medical device clinical investigations

This paper was first published by BSI in 2018 and has been revised in light of the publication of BS EN ISO 14155:2020. The paper discusses important requirements for pre-market and post-market clinical investigations under the European Medical Device Regulation (2017/745) (MDR), relevant European guidance documents and BS EN ISO 14155:2020, and how this updated standard can help in meeting MDR requirements.