CENTRO DI DOCUMENTAZIONE SUI DISPOSITIVI MEDICI

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....

The directive is one of the legal instruments available to the European institutions for implementing European Union policies. It is a flexible instrument mainly used as a means to harmonise national laws. It requires EU countries to achieve a certain result but leaves them free to choose how to do so. SUMMARY The directive is one of the legal instruments available to the European institutions for implementing European Union policies. It is a flexible instrument mainly used as a means to harmonise national laws. It requires EU countries to achieve a certain result but leaves them free to choose how to do so. The directive forms part of the EU’s  secondary law . It is therefore adopted by the EU institutions in accordance with the founding  Treaties . Once adopted at EU level, it is then transposed by EU countries into their internal law for application. For example, the  directive on the organisation of working time  sets mandatory rest periods and a lim...