Approval of revisions to key EU clinical investigation guidelines just out of reach
This article was originally published in Clinica
Executive Summary
The proposed revisions to two key EU guidelines on medical device clinical investigations have faced a slight delay to their final approval. One guideline, Meddev 2.7/ 2, is on competent authority assessment of a clinical investigation and the other, Meddev 2.7/3, is related to the reporting of serious adverse events (SAEs) during an investigation.