Europe – European Commission issues MDR Q&A document on medical device clinical investigations

The European Commission’s Medical Device Coordination Group (MDCG) has published a Q&A reference document covering clinical investigation requirements under the Medical Devices Regulation (MDR).

The new MDCG document includes 28 questions and answers, providing additional clarity on several issues regarding the MDR’s substantial clinical investigation requirements. Manufacturers preparing for the MDR’s May 26, 2021 final date of application may find this new information useful as they gear up for compliance…