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....

From website The European Commission provides a range of guidance documents to assist stakeholders in implementing directives related to medical devices. Guidance MEDDEVEs The MEDDEVs promote a common approach to be followed by manufacturers and Notified Bodies that are involved in conformity assessment procedures. The MEDDEVs are drafted by authorities charged with safeguarding public health in conjunction with all stakeholders; industry associations, health professionals associations, Notified Bodies and European Standardisation Organisations. This is in accordance with the relevant annexes of the directives MEDDEVs are carefully drafted through a consultation process with all interested parties and are subject to a regular updating process These documents have particular reference codes and are endorsed at the Medical Devices Expert Group (MDEG) plenary meetings The guidelines are not legally binding. However, due to the participation of the aforementi...