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MEDDEV2.12/2rev2January2012GUIDELINESONMEDICALDEVICESPOSTMARKETCLINICALFOLLOW-UPSTUDIESAGUIDEFORMANUFACTURERSANDNOTIFIEDBODIES关于医疗设备指导方针药品上市后临床跟踪研究指导生产商和相关人员NoteThepresentGuidelinesarepartofasetofGuidelinesrelatingtoquestionsofapplicationofEC-DirectivesonmedicalDevices.Theyarelegallynotbinding.TheGuidelineshavebeencarefullydraftedthroughaprocessofintensiveconsultationofthevariousinterestparties(competentauthorities,Commissionservices,industries,otherinterestedparties)duringwhichintermediatedraftswherecirculatedandcommentsweretakenupinthedocument.Therefore,thisdocumentreflectspositionstakenbyrepresentativesofinterestpartiesinthemedicaldevicessector.注释本准则是有关欧共体指令对医疗器械的应用问题指引的一部分。其在法律上不具约束力。该指引通过对利益相关方(主管机构,委员会服务机构,行业人员,其他利益相关各方)进行详尽征询后审慎起草的。期间,中期草案经传阅,相关建议也收录在文档中。因此,该文件体现了医疗器械各相关方代表的立场。CONTENTSIntroductionScopeReferencesDefinitionsCircumstanceswhereapostmarketclinicalfollowupstudyinindicatedElementsofapost-marketclinicalfollowupstudyTheuseofstudydataTheroleofthenotifiedbodyinpost-marketclinicalfollowup目录介绍范围参考文献定义上市后临床跟踪研究所指环境上市后临床跟踪研究原理研究数据的用法上市后临床跟踪中相关各方的作用PrefaceThisdocumentisintendedtobeaguideformanufacturersandNotifiedBodiesonhowtocarryoutPost-MarketClinicalFollow-up(PMCF)studiesinordertofulfilPost-MarketSurveillance(PMS)obligationsaccordingtoSection3.1ofAnnexII,Section3ofAnnexIV,Section3ofAnnexV,Section3.1ofAnnexVIorSection4ofAnnexVIIoftheMedicalDevicesDirective(93/42/EEC)andSection3.1ofAnnex2,Section3ofAnnex4,Section3.1ofAnnex5oftheActiveImplantableMedicalDevicesDirective(90/385/EEC).TheseSectionsrefertorequirementsofAnnexXofDirective93/42/EECandAnnex7ofDirective90/385/EEC,respectively.前言本文件旨在为生产商和相关各方提供指导,指导如何开展上市后的临床跟踪(PMCF)研究,以履行医疗器械指令(93/42/EEC)附录Ⅱ3.1,附录Ⅳ3,附录Ⅴ3,附录Ⅵ3.1或附录Ⅶ4和有源植入医疗器械指令(90/385/EEC)附录2.3.1,附录4.3,附录5.3.1中所要求的上市后市场监督(PMS)义务。这些部分分别是指令93/42/EEC附录ⅹ和指令90/385/EEC指令附录7所指要求。Attentionisdrawntoparagraph8ofArticle15ofDirective93/42/EECwhichspellsouttheprovisionsofArticle15thatarenotapplicabletoclinicalinvestigationsconducted提请注意指令93/42/EEC的第15条第8款,其阐述了第15条规定并不适用于CE标志器械用途范围内所进行的临床研究。usingCE-markeddeviceswithintheirintendeduse.SimilarlywhenPMCFstudiesareconductedusingCEmarkeddeviceswithintheirintendeduse,theprovisionsofsection2.3.5ofAnnexXofDirective93/42/EECdonotapply.However,theprovisionsofDirective93/42/EECconcerninginformationandnotificationofincidentsoccurringfollowingplacingdevicesonthemarketarefullyapplicable.同样,在CE标志器械用途范围内进行PMCF研究时,指令93/42/EEC附录ⅹ第2.3.5条的规定也不适用。然而,指令93/42/EEC的条款关于在市场上放置以下设备出现的事件信息和通知是完全适用的。1.IntroductionWhileclinicalevidenceisanessentialelementofthepremarketconformityassessmentprocesstodemonstrateconformitytoEssentialRequirements,itisimportanttorecognisethattheremaybelimitationstotheclinicaldataavailableinthepre-marketphase.Suchlimitationsmaybeduetothedurationofpre-marketclinicalinvestigations,thenumberofsubjectsandinvestigatorsinvolvedinaninvestigation,therelativeheterogeneityofsubjectsandinvestigatorsand/orthecontrolledsettingofaclinicalinvestigationversusthefullrangeofclinicalconditionsencounteredingeneralmedicalpractice.1介绍虽然临床证据是上市前合格评定程序的基本要素,以证实符合基本要求,但是重要的是认识到在上市前阶段现有的临床数据可能存在局限性。这种局限性可能是由于上市前临床调查的期限、涉及到调查的主题和人员数量、主题和人员相对差异性和/或者在一般医疗实践中遇到的临床调查与全方位临床条件的控制设置所引起的。ApreconditionforplacingaproductonthemarketisthatconformitytotherelevantEssentialRequirements,includingafavourablebenefit/riskratio,hasbeendemonstrated.Theextentofthedatathatcanbegatheredinthepre-marketphasedoesnotnecessarilyenablethemanufacturertodetectrarecomplicationsorproblemsthatonlybecomeapparentafterwide-spreadorlongtermuseofthedevice.Aspartofthemanufacturer’squalitysystem,anappropriatepost-marketsurveillanceplaniskeytoidentifyingandinvestigatingresidualrisksassociatedwiththeuseofmedicaldevicesplacedonthemarket.Theseresidualrisksshouldbeinvestigatedandassessedinthepost-marketphasethroughsystematicPost-MarketClinicalFollow-up(PMCF)study(ies).在市场上放置一种产品的先决条件是符合相关基本要求,其中包括一个合适的利益/风险比,这一观点已被证实。器械经广泛和长期应用后,上市前阶段收集的数据也并不一定能让生产商可以检测出罕见的并发症或是仅有在经过长期使用后才呈现的问题。作为生产商质量体系的一部分,一个合适的上市后监测程序的关键是识别和调查与投放市场的医疗器械应用相关的残余风险。这些残余风险应该在上市后阶段通过系统的上市后临床跟踪研究进行调查和评估。Clinicaldataobtainedfrompost-marketsurveillanceandduringPMCFstudiesbythemanufacturerarenotintendedtoreplacethepre-marketdatanecessarytodemonstrateconformitywiththeprovisionsofthelegislation.However,theyarecriticaltoupdatetheclinicalevaluationthroughoutthelife-cycleofthemedicaldeviceandtoensurethelongtermsafetyandperformanceofdevicesaftertheirplacingonthemarket.生产商在上市后监察和上市后临床跟踪研究中获得的临床数据并不能替代必要的上市前数据,其用来证实有关法例的规定。然而,关键是更新医疗器械的整个生命周期的临床评价并确保投放于市场上后的器械长期安全性和性能性。PMCFstudiesareoneofseveraloptionsavailableinpost-marketsurveillanceandcontributetotheriskmanagementprocess.上市后临床跟踪研究是上市后监察中几个可用选择之一,并有助于风险管理过程。2.ScopeTheobjectiveofthisdocumentistoprovideguidanceontheappropriateuseandconductofPMCFstudiestoaddressissueslinkedtoresidualrisks.Theintentionisnot2范围本文件的目的是提供恰当的使用指引和进行上市后临床跟踪研究,以解决相关残余风险的问题。并不旨在实施新的监管要求。toimposenewregulatoryrequirements.PMCFstudiesareanimportantelementtobeconsideredinPMCForPMSplans.TheprinciplesforPMCFstudiessetoutinthisguidancearenotintendedtoreplacePMCF
本文标题:MEDDEV-2.12.2rev2Post-Market-Clinical-Follow-up-st
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