Guidelines on Medical Devices

A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC

Introduction

Pursuant to

– section 6a of Annex I to Directive 93/42/EEC (amended by Directive 2007/47/EC) and to

– section 5a of Annex 1 to Directive 90/385/EEC (amended by Directive 2007/47/EC),

the demonstration of conformity with Essential Requirements for a medical device must include a clinical evaluation, which is conducted in accordance with Annex X to Directive 93/42/EEC or with Annex 7 to Directive 90/385/EEC.

This document promotes a common approach to clinical evaluation for medical devices regulated by directives 90/385/EEC and 93/42/EEC. It does not concern in vitro diagnostic devices.

The depth and extent of clinical evaluations should be flexible and appropriate to the nature, intended purpose, and risks of the device in question. Therefore, this guidance is not intended to impose device-specific requirements.

This document uses the terms “must”, “shall”, “have to” where these terms are used in the Directives. “Should” is used in other instances.