This document is intended for sponsors of clinical investigations of medical devices conducted within the scope of the Regulation (EU) 2017/745 (MDR)
This guidance covers important topics as:
– clinical investigation definitions in the context of EU MDR
– general differences from MDD and MDR
– regulatory pathways to investigational devices and CE mark devices
– substantial modifications
– safety requirements
– Clinical Investigation reports
MDCG 2021-6 Questions & Answers regarding Clinical Investigations