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EUROPEANCOMMISSIONDGInternalMarket,Industry,EntrepreneurshipandSMEsConsumer,EnvironmentalandHealthTechnologiesHealthtechnologyandCosmetics备注：中文翻译中的临床调查=临床研究，评估=评价、设备=器械、数据=资料MEDDEV2.7/1revision4June2016GUIDELINESONMEDICALDEVICES医疗器械指南CLINICALEVALUATION:AGUIDEFORMANUFACTURERSANDNOTIFIEDBODIESUNDERDIRECTIVES93/42/EECand90/385/EECNoteThepresentGuidelinesarepartofasetofGuidelinesrelatingtoquestionsofapplicationofEC-DirectivesonmedicalDevices.Theyarelegallynotbinding.TheGuidelineshavebeencarefullydraftedthroughaprocessofintensiveconsultationofthevariousinterestedparties(competentauthorities,Commissionservices,industries,otherinterestedparties)duringwhichintermediatedraftswherecirculatedandcommentsweretakenupinthedocument.Therefore,thisdocumentreflectspositionstakenbyrepresentativesofinterestpartiesinthemedicaldevicessector.TheseguidelinesincorporatechangesintroducedbyDirective2007/47/ECamendingCouncilDirective90/385/EECandCouncilDirective93/42/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（没规定实施时间）MEDICALDEVICESDIRECTIVESCLINICALINVESTIGATIONCLINICALEVALUATION:AGUIDEFORMANUFACTURERSANDNOTIFIEDBODIESUNDERDIRECTIVES93/42/EECand90/385/EECIndex1.Introduction.......................................................................................................................42.Scope...............................................................................................................................43.References.........................................................................................................................44.Definitions.........................................................................................................................55.Abbreviations....................................................................................................................86.Generalprinciplesofclinicalevaluation.............................................................................96.1.Whatisclinicalevaluation?................................................................................................96.2.Whenisclinicalevaluationundertakenandwhyisitimportant?......................................106.2.1.Clinicalevaluationundertakenforthedevelopmentofamedicaldevice.........................106.2.2.ClinicalevaluationforinitialCE-marking..........................................................................116.2.3.Updatingtheclinicalevaluation........................................................................................116.3.Howisaclinicalevaluationperformed?...........................................................................136.4.Whoshouldperformtheclinicalevaluation?....................................................................147.Definitionofthescopeoftheclinicalevaluation(Stage0)...............................................158.Identificationofpertinentdata(Stage1)...........................................................................178.1.Datageneratedandheldbythemanufacturer.................................................................178.2.Dataretrievedfromliterature............................................................................................189.Appraisalofpertinentdata(Stage2)................................................................................199.1.Generalconsiderations.....................................................................................................199.2.Theappraisalplan............................................................................................................209.3.Conductoftheappraisal...................................................................................................209.3.1.Howtoevaluatemethodologicalqualityandscientificvalidity.........................................209.3.2.Howtodeterminetherelevanceofadatasetfortheclinicalevaluation..........................249.3.3.Howtoweightthecontributionofeachdataset...............................................................2610.Analysisoftheclinicaldata(Stage3)...............................................................................2710.1.Generalconsiderations.....................................................................................................2710.2.Specificconsiderations.....................................................................................................2710.3.Wheredemonstrationofconformitybasedonclinicaldataisnotdeemedappropriate...2911.Theclinicalevaluationreport(CER,Stage4)..................................................................2912.Theroleofthenotifiedbodyintheassessmentofclinicalevaluationreports..................31Appendices....................................................................................................................................32A1.Demonstrationofequivalence........................