MEDDEV 2.7.1rev42016附中文

MEDDEV2.71 revision 4 June 2016 Guidelines on Medical Devices Clinical Evaluation:A Guide for Manufacturers And Notified Bodies Under Directives 9342EEC and 90385EEC


DG Internal Market, Industry, Entrepreneurship and SMEs

Consumer, Environmental and Health Technologies

Health technology and Cosmetics


MEDDEV 2.7.1rev42016附中文

MEDDEV 2.7.1rev42016附中文

MEDDEV 2.7.1rev42016附中文


The present Guidelines are part of a set of Guidelines relating to questions of application of EC-Directives on medical Devices. They are legally not binding. The Guidelines have been carefully drafted through a process of intensive consultation of the various interested parties (competent authorities, Commission services, industries, other interested parties) during which intermediate drafts where circulated and comments were taken up in the document. Therefore, this document reflects positions taken by representatives of interest parties in the medical devices sector. These guidelines incorporate changes introduced by Directive 2007/47/EC amending Council Directive 90/385/EEC and Council Directive 93/42/EEC.

本指南为一系列与CE—医疗器械指令应用问题相关的指南中的一部分。并不具有法律约束力。该指南在经过与各个利益方(主管当局、服务委员会、行业委员会、其他利益相关团体)进行深入协商之后谨慎拟定而成,期间对中期草案进行了传阅,而且部分意见还为本文件所采纳。因此,本文件反映出了来自医疗器械行业的利益团体代表所持的立场。本指南包含了指令 2007/47/EC对90/385/EEC和 93/42/EEC修正中的变更


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