欧盟临床评价.docx

EUROPEAN COMMISSIONDG Internal Market, Industry, Entrepreneurship and SMEs Consumer, Environmental and Health TechnologiesHealth technology and CosmeticsMEDDEV 2.7/1 revision 4June 2016GUIDELINES ON MEDICAL DEVICESCLINICAL EVALUATION:A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EECNoteThe 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 INVESTIGATIONCLINICAL EVALUATION:A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EECIndexIntroduction4Scope4References4Definitions5Abbreviations8General principles of clinical evaluation9What is clinical evaluation?9When is clinical evaluation undertaken and why is it important?10Clinical evaluation undertaken for the development of a medical device10Clinical evaluation for initial CE-marking11Updating the clinical evaluation11How is a clinical evaluation performed?13Who should perform the clinical evaluation?14Definition of the scope of the clinical evaluation (Stage 0)15Identification of pertinent data (Stage 1)17Data generated and held by the manufacturer17Data retrieved from literature18Appraisal of pertinent data (Stage 2)19General considerations.19The appraisal plan20Conduct of the appraisal.20How to evaluate methodological quality and scientific validity20How to de