Clinical Evidence

Clinical Evidence

Leitlinie

This document is the first produced by Study Group 5 and is intended to: • introduce the concepts of clinical evaluation and clinical evidence; • examine the relationship between clinical investigation, clinical data, clinical evaluation and clinical evidence; and • serve as guidance to all those involved in the generation, compilation and review of clinical evidence sufficient to support the marketing of medical devices (regulatory authorities, conformity assessment bodies, manufacturers of medical devices and their associated industry groups).