Medical device CE marking

MDCG 2021-6 MDR – Questions & Answers regarding clinical investigation – Rev.1


On December 12, the MDCG published Revision 1 of guidance 2021-6: Regulation (EU) 2017/745 ̶ Questions & Answers regarding clinical investigations, a document that answers many outstanding questions relating to clinical investigations.

The guidance deals with the fundamental issue of what the general differences and improvements related to clinical investigations are under the MDR as compared with the medical device directives and is broken into sections dealing with the following topics: general questions; modifications; timeline considerations; clinical investigation reports; and arrangements for the transitional period.

The document can be downloaded in our library.

Source: European Commission.