EUROPEAN COMMISSION DG Internal Market, Industry, Entrepreneurship and SMEs Consumer, Environmental and Health Technologies Health technology and Cosmetics 備注：中文翻譯中的臨床調(diào)查=臨床研究，評估=評價(jià)、設(shè)備=器械、數(shù)據(jù)=資料 MEDDEV 2.7/1 revision 4 June 2016 GUIDELINES ON MEDICAL DEVICES 醫(yī)療器械指南 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. 本指南為一系列與CE—醫(yī)療器械指令應(yīng)用問題相關(guān)的指南中的一部分。

并不具有法律約束力該指南在經(jīng)過與各個(gè)利益方（主管當(dāng)局、服務(wù)委員會、行業(yè)委員會、其他利益相關(guān)團(tuán)體）進(jìn)行深入?yún)f(xié)商之后謹(jǐn)慎擬定而成，期間對中期草案進(jìn)行了傳閱，而且部分意見還為本文件所采納因此，本文件反映出了來自醫(yī)療器械行業(yè)的利益團(tuán)體代表所持的立場本指南包含了指令 2007/47/EC對90/385/EEC和 93/42/EEC修正中的變更 （沒規(guī)定實(shí)施時(shí)間） MEDICAL DEVICES DIRECTIVES CLINICAL INVESTIGATION CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC Index 1. Introduction....................................................................................................................... 4 2. Scope ............................................................................................................................... 4 3. References ......................................................................................................................... 4 4. Definitions......................................................................................................................... 5 5. Abbreviations.................................................................................................................... 8 6. General principles of clinical evaluation ............................................................................. 9 6.1. What is clinical evaluation? ................................................................................................ 9 6.2. When is clinical evaluation undertaken and why is it important?...................................... 10 6.2.1. Clinical evaluation undertaken for the development of a medical device ......................... 10 6.2.2. Clinical evaluation for initial CE-marking .......................................................................... 11 6.2.3. Updating the clinical evaluation ........................................................................................ 11 6.3. How is a clinical evaluation performed? ........................................................................... 13 6.4. Who should perform the clinical evaluation? .................................................................... 14 7. Definition of the scope of the clinical evaluation (Stage 0) ............................................... 15 8. Identification of pertinent data (Stage 1)........................................................................... 17 8.1. Data generated and held by the manufacturer ................................................................. 17 8.2. Data retrieved from literature............................................................................................ 18 9. Appraisal of pertinent data (Stage 2) ................................................................................ 19 9.1. General considerations..................................................................................................... 19 9.2. The appraisal plan ............................................................................................................ 20 9.3. Conduct of the appraisal................................................................................................... 20 9.3.1. How to evaluate methodological quality and scientific validity ......................................... 20 9.3.2. How to determine the relevance of a data set for the clinical evaluation.......................... 24 9.3.3. How to weight the contribution of each data set............................................................... 26 10. Analysis of the clinical data (Stage 3)............................................................................... 27 10.1. General considerations..................................................................................................... 27 10.2. Specific considerations..................................................................................................... 27 10.3. Where de。