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MEDDEV 2.7/1 revision 4 MEDDEV 2.7/1 revision 4 page PAGE 18 of 65 EUROPEAN COMMISSION DG Internal Market, Industry, Entrepreneurship and SMEs Consumer, Environmental and Health Technologies Health technology and Cosmetics MEDDEV MEDDEV 2.7/1 revision 4 June 2016 GUIDELINES GUIDELINES ON MEDICAL DEVICES CLINICAL CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC Note 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. MEDICAL DEVICES DIRECTIVES CLINICAL INVESTIGATION CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC Index HYPERLINK \l _bookmark0 Introduction HYPERLINK \l _bookmark0 4 HYPERLINK \l _bookmark1 Scope HYPERLINK \l _bookmark1 4 HYPERLINK \l _bookmark2 References HYPERLINK \l _bookmark2 4 HYPERLINK \l _bookmark3 Definitions HYPERLINK \l _bookmark3 5 HYPERLINK \l _bookmark4 Abbreviations HYPERLINK \l _bookmark4 8 HYPERLINK \l _bookmark5 General principles of clinical evaluation HYPERLINK \l _bookmark5 9 HYPERLINK \l _bookmark6 What is clinical evaluation? HYPERLINK \l _bookmark6 9 HYPERLINK \l _bookmark7 When is clinical evaluation undertaken and why is it important? HYPERLINK \l _bookmark7 10 HYPERLINK \l _bookmark8 Clinical evaluation undertaken for the development of