MEDDEV2122rev2Word格式文档下载.docx
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2.Scope..........................................................................................................................................4
3.References..................................................................................................................................4
4.Definitions..................................................................................................................................6
5.Circumstanceswhereapostmarketclinicalfollowupstudyinindicated.................................8
6.Elementsofapost-marketclinicalfollowupstudy.................................................................10
7.Theuseofstudydata................................................................................................................12
8Theroleofthenotifiedbodyinpost-marketclinicalfollowup..............................................12
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Preface
ThisdocumentisintendedtobeaguideformanufacturersandNotifiedBodieson
howtocarryoutPost-MarketClinicalFollow-up（PMCF）studiesinordertofulfil
Post-MarketSurveillance（PMS）obligationsaccordingtoSection3.1ofAnnexII,
Section3ofAnnexIV,Section3ofAnnexV,Section3.1ofAnnexVIorSection4
ofAnnexVIIoftheMedicalDevicesDirective（93/42/EEC）andSection3.1of
Annex2,Section3ofAnnex4,Section3.1ofAnnex5oftheActiveImplantable
MedicalDevicesDirective（90/385/EEC）.TheseSectionsrefertorequirementsof
AnnexXofDirective93/42/EECandAnnex7ofDirective90/385/EEC,respectively.
Attentionisdrawntoparagraph8ofArticle15ofDirective93/42/EECwhichspells
outtheprovisionsofArticle15thatarenotapplicabletoclinicalinvestigations
conductedusingCE-markeddeviceswithintheirintendeduse.
SimilarlywhenPMCFstudiesareconductedusingCEmarkeddeviceswithintheir
intendeduse,theprovisionsofsection2.3.5ofAnnexXofDirective93/42/EECdo
notapply.However,theprovisionsofDirective93/42/EECconcerninginformation
andnotificationofincidentsoccurringfollowingplacingdevicesonthemarketare
fullyapplicable.
.
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1.Introduction
Whileclinicalevidenceisanessentialelementofthepremarketconformity
assessmentprocesstodemonstrateconformitytoEssentialRequirements,itis
importanttorecognisethattheremaybelimitationstotheclinicaldataavailablein
thepre-marketphase.Suchlimitationsmaybeduetothedurationofpre-market
clinicalinvestigations,thenumberofsubjectsandinvestigatorsinvolvedinan
investigation,therelativeheterogeneityofsubjectsandinvestigatorsand/orthe
controlledsettingofaclinicalinvestigationversusthefullrangeofclinicalconditions
encounteredingeneralmedicalpractice.
Apreconditionforplacingaproductonthemarketisthatconformitytotherelevant
EssentialRequirements,includingafavourablebenefit/riskratio,hasbeen
demonstrated.Theextentofthedatathatcanbegatheredinthepre-marketphase
doesnotnecessarilyenablethemanufacturertodetectrarecomplicationsorproblems
thatonlybecomeapparentafterwide-spreadorlongtermuseofthedevice.Aspartof
themanufacturer’squalitysystem,anappropriatepost-marketsurveillanceplaniskey
toidentifyingandinvestigatingresidualrisksassociatedwiththeuseofmedical
devicesplacedonthemarket.Theseresidualrisksshouldbeinvestigatedandassessed
inthepost-marketphasethroughsystematicPost-MarketClinicalFollow-up（PMCF）
study（ies）.
Clinicaldataobtainedfrompost-marketsurveillanceandduringPMCFstudiesbythe
manufacturerarenotintendedtoreplacethepre-marketdatanecessarytodemonstrate
conformitywiththeprovisionsofthelegislation.However,theyarecriticaltoupdate
theclinicalevaluationthroughoutthelife-cycleofthemedicaldeviceandtoensure
thelongtermsafetyandperformanceofdevicesaftertheirplacingonthemarket.
PMCFstudiesareoneofseveraloptionsavailableinpost-marketsurveillanceand
contributetotheriskmanagementprocess.
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2.Scope
Theobjectiveofthisdocumentistoprovideguidanceontheappropriateuseand
conductofPMCFstudiestoaddressissueslinkedtoresidualrisks.Theintentionis
nottoimposenewregulatoryrequirements.本文档的目的是提供指导,对合理使用
PMCF进行研究,用以解决问题与残留的风险。
其目的是不实施新的法规要求
PMCFstudiesareanimportantelementtobeconsideredinPMCForPMSplans.The
principlesforPMCFstudiessetoutinthisguidancearenotintendedtoreplacePMCF
orPMSplans.TheyareormaybeapplicabletoPMCFstudiesconductedforother
purposes.PMCF研究是一项重要的因素来考虑PMCF或pms计划。
这个PMCF原则研究中提出指导不是为了取代或PMS计划。
他们是或可能也适用于PMCF研究其他目的。
Thisdocumentprovidesguidanceinrelationto:
本文档提供了指导有关:
i）
ii）
iii）
thecircumstanceswhereaPMCFstudyisindicated;
这个情况下的一个PMCF研究;
thegeneralprinciplesofPMCFstudiesinvolvingmedicaldevices;
PMCF的一般原理研究涉及医疗设备;
theuseofstudydata（forexampletoupdateinstructionsforuseandlabelling）;
研究数据的使用（例如更新使用说明和标签）;
and
iv）
theroleofanotifiedbodyformedicaldevicesintheassessmentofPMCFplans
andoftheresultsobtainedfromtheplansaspartofconformityassessment.为医疗设备评估PMCF计划和该计划获取结果作为符合性评估一部份的公告机构的角色
Thisdocumentdoesnotapplytoinvitrodiagnosticdevices.本文档并不适用于体外诊断设备。
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3.References
CouncilDirective93/42/EECof14June1993concerningmedicaldevicesaslast
amendedbyDirective2007/47/ECoftheEuropeanParliamentandoftheCouncilof
5September2007.欧洲议会和理事会1993年6月14日关于医疗设备委员会指令93/42/EEC的修改指令2007/47/EC,2007年9月5日
CouncilDirective90/385/EECof20June1990ontheapproximationofthelawsof
theMemberStatesrelatingtoactiveimplantablemedicaldeviceslastamendedby
Directive2007/47/ECoftheEuropeanParliamentandoftheCouncilof5September
1990年6月20日委员会指令90/385/EEC的及最后修正指令2007/47/EC,欧洲议会和理事会2007年9月5日
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InterpretativeDocuments
MEDDEV2.7.1
ClinicalEvaluation:
AGuideforManufacturersandNotified
Bodies
MEDDEV2.7.1,Appendix1
EvaluationofClinicalData–AGuideforManufacturersand
NotifiedBodies–Appendix1:
ClinicalEvaluationofCoronary
Stents
GHTFFinalDocuments:
SG1/N41:
2005
SG1/N44:
2008
SG1/N065:
2010
EssentialPrinciplesofSafety&
PerformanceofMedicalDevices医疗设备安全和性能的基本原则
TheRoleofStandardsintheAssessmentofMedicalDevices标准在医疗设备评价中的作用
RegistrationofManufacturersandOtherPartiesandListingof
MedicalDevices
SG2/N47:
SG5/N1:
2007
SG5/N2:
SG5/N3:
ReviewofCurrentRequirementsonPost-MarketSurveillance
ClinicalEvidence–KeyDefinitionsandConcepts
ClinicalEvaluation
ClinicalInvestigations
InternationalStandards:
ENISO14155:
2011ClinicalinvestigationofMedicalDevicesforhumansubjects
Goodclinicalpractice;
Secondedition2011-02-01
ENISO14971:
2009
Others:
Applicationofriskmanagementtomedicaldevices
USDepartmentofHealthandHumanService,AgencyforHealthcareResearch
andQuality:
RegistriesforEvaluatingPatientOutcomes:
aUser’sGuide（Executive
Summary,April2007）.
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1
4.Definitions
ClinicalData1:
Thesafetyand/orperformanceinformationthatisgeneratedfromtheuseofa
device.由使用设备所产生的安全性和/或性能信息
Clinicaldataaresourcedfrom:
-
clinicalinvestigation（s）ofthedeviceconcerned;
or设备的临床调查（s）;
或
clinicalinvestigation（s）orotherstudiesreportedinthescientificliterature
ofasimilardeviceforwhichequivalencetothedeviceinquestioncanbe
demonstrated;
or在科学文献中报道一个类似的设备的临床调查（s）或其他的研究,相关的安全性问题都可以被证实
证明;
publishedand/orunpublishedreportsonotherclinicalexperienceofeither
thedeviceinquestionorasimilardeviceforwhichequivalencetothe
deviceinquestioncanbedemonstrated.出版和/或未出版的报告在其他的临床经验或者
设备的关键设备,或类似的等价性可以证明其装置的难题。
ClinicalEvaluation2:
Theassessmentandanalysisofclinicaldatapertainingtoamedicaldeviceto
verifytheclinicalsafetyandperformanceofthedevicewhenusedasintended
bythemanufacturer.由制造商评估和分析临床数据以验证医疗设备临床的性能和安全性
ClinicalEvidence2:
Theclinicaldataandtheclinicalevaluationreportpertainingtoa
升级会员 