EUROPEAN COMMISSION
DG
Internal Market, Industry, Entrepreneurship and SMEs
Consumer, Environmental and Health Technologies
Health technology and Cosmetics
ABSTRACT
1. 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.
2. Scope
This guide is not legally binding; only the text of the Directives is authentic in law. It is recognised
that under given circumstances, for example as a result of scientific developments, an alternative
approach may be possible or appropriate to comply with the legal requirements.
Nevertheless, due to the participation of interested parties and of experts from national Competent
Authorities, it is anticipated that this guide will be followed within the Member States, thereby
supporting uniform application of relevant provisions of EU Directives and common practices.
On certain issues not addressed in the Directives, national legislation may be different from this
guide.
This guide is regularly updated according to regulatory developments. The latest version of the
guide should always be used. This version is a complete revision of the previous texts.
The medical device legislation in Europe is currently being significantly revised. A new Regulation
of the European Parliament and of the Council on medical devices will be published, which may
result in changes to important concepts or definitions relating to clinical evaluation. Parts or all of
this document are likely to be revised. Some contents (such as contents about notified bodies) are
likely to be removed and integrated in other series of documents.
