Clinical Evidence
Title:
Clinical Evidence
Origin/Publisher:
GHTF
Document Type:
Guideline
Content:
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).