scope:

The primary purpose of this document is to provide manufacturers and notified bodies with guidance on how to conduct and document the clinical evaluation of a medical device as part of the conformity assessment procedure prior to placing a medical device on the market as well as to support its ongoing marketing. It is also intended to provide guidance to regulators and other stakeholders when assessing clinical evidence provided by manufacturers.

This document provides the following guidance:

· general principles of clinical evaluation;

· how to identify relevant clinical data to be used in a clinical evaluation;

· how to appraise and integrate clinical data into a summary; and

· how to document a clinical evaluation in a clinical evaluation report.

The guidance contained within this document is intended to apply to medical devices generally and the device component of combination products. It is not intended to cover in vitro diagnostics.