The MDCG issued a Questions & Answers (Q&A) document aimed at assisting sponsors by clarifying certain aspects of clinical investigation of medical devices within the bounds of the Regulation (EU) 2017/745 (MDR).
This document provides a more detailed overview concerning general subjects such as definitions of relevant concepts, regulatory pathways, responsibilities, and other specific requirements of clinical investigations. The Q&A also refers to modifications to clinical investigations, timelines, reports, and arrangements . . .
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