上市后临床跟踪管理系统程序

1、上市后临床追踪管理系统程序合用文档上市后临床追踪控制程序文件编号：QP-29版本：A/0见效日期：页码：19编制：审察：赞同：PURPOSEThepurposeofthisworkinstructionistodefinetheprocesstodetermineanddocumentwhetherapost-marketclinicalfollow-upstudyisrequiredforTDIFoot/AnkleArray8chmedicaldevicesbearingtheCEmark.Theprocesswillleadtoadeterminationofwhetherapost-ma

2、rketclinicalfollow-upstudyisrequiredandprovideguidanceforpost-marketclinicalmonitoringrequirementsifastudyisnotrequired.2.SCOPETheworkinstructionappliestoallmedicaldevicebusinessesandsitesoperatingundertheTDIFoot/AnkleArray8chHealthcareQualityManagementSystem.OnlymedicaldevicesbearingtheCEMarkwillbe

3、requiredtofollowthisworkinstruction.3.REFERENCES3.1.ExternalReferences3.1.1.LawsCouncilDirective93/42/EECof14June1993concerningmedicaldevicesincludingamendmentsthrough05September20073.1.2.GuidanceDocumentsEuropeanCommissionEnterprise-Directorate-GeneralMEDDEV2.12-2GuidelinesonPostMarketClinicalFollo

4、w-UpdatedMay2004MEDDEV2.7.1Rev.3guidelinesonmedicaldevice-clinicalevaluation-aguideformanufacturersandnotifiedbodiesdatedApril2009GHTFPost-MarketClinicalFollow-UpStudies;SG5(PD)N4R7(Proposeddocument23July2008)GHTFClinicalInvestigations;SG5(PD)N3R7(20January2008)文案大全1/19ProductRegulatoryAffairsRepres

5、entativeRegulatoryAffairsRepresentative上市后临床追踪管理系统程序合用文档4.ROLESANDRESPONSIBILITIESImportant:Whenatitleofapositionislistedinthisworkinstruction,itrelatestothatpositionoritsequivalent.Belowaretherolesandresponsibilitiesdiscussedwithinthisdocument.Table4-1:RolesandResponsibilitiesRoleResponsibilityDesi

6、gnEngineeringProvideconsultationtotheProductRegulatoryAffairsand/orEngineeringRepresentativeindeterminingforagivenproject/productRepresentativewhetherapost-marketclinicalfollow-upstudyisrequiredProvideconsultationtotheProductRegulatoryAffairsRepresentativetodetermineifanequivalentdeviceexistsProvide

7、consultationtotheProductRegulatoryAffairsRepresentativeinidentifyingemergingrisksforthemedicaldeviceProvideconsultationtotheResearchManagerordesigneetodeterminethetypeofpost-marketclinicalfollow-upstudytobeimplemented,ifapplicableDetermineforagiveproject/productwhetherapost-marketclinicalfollow-upst

8、udyisrequiredDetermineifanequivalentdeviceexistsIdentifypotentialemergingrisksReviewriskassessmentCompletethePost-MarketClinicalFollow-UpJustificationFormregardingdecisiontoperformastudyCompletethePost-MarketClinicalFollow-UpPlanformthatdetailsthepost-marketclinicalfollow-upplanDeterminehowoftenclin

9、icaldatamustbereviewedReviewandapprovetheclinicalevaluationperformedbytheResearchManagerordesigneeProvideconsultationtotheResearchManagertodeterminethetypeofpost-marketclinicalfollow-upstudytobeimplemented,ifapplicable文案大全2/19上市后临床追踪管理系统程序合用文档Table4-1:RolesandResponsibilitiesRoleResponsibilityResear

10、chManagerorProvideconsultationtotheProductRegulatoryAffairsdesigneeRepresentativeindeterminingforagivenproject/productwhetherapost-marketclinicalfollow-upstudyisrequiredProvideconsultationtotheProductRegulatoryAffairsRepresentativetodetermineifanequivalentdeviceexistsProvideconsultationtotheProductR

11、egulatoryAffairsRepresentativetoidentifypotentialemergingrisksReviewthePost-MarketClinicalFollow-UpJustificationformandPost-MarketClinicalFollow-UpPlanformtoconfirmthedecisionsregardingtheneedforapost-marketclinicalfollow-upstudyandclinicalfollow-upDeterminehowoftenclinicaldatamustbereviewedDetermin

12、ethetypeofpost-marketclinicalfollow-upstudytobeimplemented,ifapplicableReviewnewdata(i.e.literature,adverseevents,complaints,etc,)anddetermineifapost-marketclinicalfollow-upstudyisnecessarybasedonnewinformation(clinicalevaluation)MedicalAffairsReviewthePost-MarketClinicalFollow-UpJustificationforman

13、dRepresentativePost-MarketClinicalFollow-UpPlanformtoconfirmthedecisionsregardingtheneedforapost-marketclinicalfollow-upstudyandclinicalfollow-upReviewandapprovetheclinicalevaluationperformedbytheResearchManagerordesignee5.WORKINSTRUCTIONPost-marketclinicalmonitoringisanessentialelementinestablishin

14、glongtermsafetyfollow-updataandpossibleemergentrisksformedicaldevices.Theserisksanddatacannotadequatelybedetectedandcharacterizedbyrelyingsolelyonpre-marketclinicalinvestigations.Postmarketclinicalmonitoringmayincludeacombinationofseveralstrategies:ProductcomplaintreviewPost-marketeventreportingrevi

15、ewofusersandpatientsLiteraturereviewPost-marketclinicalfollow-upstudies(PMCFS)ThisworkinstructionwascreatedtodeterminewhenaPMCFSisnecessarytomaintainanadequatepost-marketsurveillancesystem,asrequiredby文案大全3/19上市后临床追踪管理系统程序合用文档theMedicalDeviceDirective93/42/ECC(MDD)asamendedbyMDD2007/47/EC.Itwillalso

16、provideguidanceonthepost-marketclinicalmonitoringrequirementsifaPMCFSisnotrequired.Figure5-1:High-LevelProcessOverviewforPost-MarketClinicalFollow-UpDeterminewhetheranequivalentdeviceexistsIdentifyresidualrisks/emergingrisksPMCFSDeterminationReviewRiskAssessmentdocumentEvaluateneedforPMCFSPMCFSRequi

17、red?YESNOPerformPMCFSinaccordancewithGEHC_GQP_10.03andAtaminimum,reviewclinicaldataincluding,AE抯,complaintsandliteratureReviewnewdataanddeterminetheneedtoaPMCFSbasedonnewinformation5.1.GeneralRequirements5.1.1.PriortoM3sign-off,theProductRegulatoryAffairsRepresentativeinconsultationwiththeResearchMa

18、nagerordesigneeandtheDesignEngineeringand/orEngineeringRepresentativeshalldetermineforagivenproject/programwhetheraPMCFSisrequired.Theyshallalsodeterminethepost-marketclinicalfollow-upplan.5.1.2.APMCFSmaynotberequiredforproductsforwhichmedium/long-termclinicalperformanceandsafetyisalreadyknownfrompr

19、evioususeofthedeviceorwhereotherappropriatepost-marketsurveillanceactivitieswouldprovidesufficientdatatoaddresstherisks.文案大全4/19上市后临床追踪管理系统程序合用文档5.2.DeterminingtheTypeofPost-MarketClinicalFollow-UpRequiredPost-marketclinicalmonitoringshallhaveoneoftwooutcomes,(1)PMCFSrequiredor(2)noPMCFSrequired.The

20、needforaPMCFSshallbebasedonacombinationofseveralfactorsdetailedinthissection.5.2.1.TheProductRegulatoryAffairsRepresentativeinconsultationwiththeResearchManagerordesigneeandDesignEngineeringand/orEngineeringRepresentativeshalldeterminewhetheranequivalentdeviceexists.Equivalenceshallbedemonstratedina

21、lltheessentialcharacteristicspreciselydefinedbelow.Equivalencemeans:ClinicalUsedforthesameclinicalconditionorpurpose;Usedatthesamesiteinthebody;Usedinsimilarpopulation(includingage,anatomy,physiology);HavesimilarrelevantcriticalperformanceaccordingtoexpectedclinicaleffectforspecificintendeduseTechni

22、calUsedundersimilarconditionsofuse;Havesimilarspecificationsandproperties;Beofsimilardesign;UsesimilardeploymentmethodsHavesimilarprinciplesofoperationBiologicalSameorsimilaruseofmaterialsincontactwithhumantissuesorbodyfluids5.2.2.Productsforwhichthemedium/longtermclinicalperformanceandsafetyisalrea

23、dyknownfromprevioususeofthedevice,orfromfullytransferableexperiencewithequivalentdevicesshallnotrequireaPMCFS.NOTE:Ifthedevicequotedas“”thentheequivalentrequiresaPMCFS,thenewproductshallbesubjecttothesamerequirement.5.2.3.TheneedforaPMCFSshallbedeterminedbasedontheidentificationofresidualrisksthatma

24、yimpacttherisk/benefitratio.Astudyshould文案大全5/19上市后临床追踪管理系统程序合用文档alwaysbeconsideredfordeviceswheretheidentificationofpossibleemergingrisksandtheevaluationoflongtermsafetyandperformanceareessential.TheProductRegulatoryAffairsRepresentativeinconsultationwiththeResearchManagerordesigneeandDesignEnginee

25、ringand/orEngineeringRepresentativeshallidentifysuchemergingrisk,thefollowingcriteriashouldbetakenintoaccount:innovation,e.g.,wherethedesignofthedevice,thematerials,theprinciplesofoperation,thetechnologyorthemedicalindicationsarenovel;highriskanatomicallocations(i.e.,heart,centralnervoussystem,etc.)

26、;severityofdisease/treatmentchallenges;sensitivityoftargetpopulation(i.e.,infants,children,pregnantwomen,etc.);identificationofanacceptableriskduringthepre-CEclinicalevaluation,whichshouldbemonitoredinalongertermand/orthroughalargerpopulation;wellknownrisksidentifiedfromtheliteratureorsimilarmarkete

27、ddevices;discrepancybetweenthepre-marketfollow-uptimescalesandtheexpectedlifeoftheproduct;5.2.4.Aproperlyconductedriskanalysisisessentialindeterminingwhatclinicalevidencemaybeneededforaparticulardevice.Anyrisksidentifiedasan“unacceptable”riskattheconclusionofthedevelopmentprocessshallrequireaPMCFS.A

28、studyshouldalsobeconsideredforrisksidentifiedas“acceptable”or“riskmitigationrequired”ifthedevicemeetsanyoftheothercharacteristicsidentifiedin5.2.1and5.2.2.TheriskassessmentshallbeperformedaccordingtotheRiskManagementProcedure.TheProductRegulatoryAffairsRepresentativeshallreviewtheriskassessment.5.2.

29、5.TheProductRegulatoryAffairsRepresentativeshallcompletethePostMarketClinicalFollow-UpStudyDeterminationForm(AppendixA)oncethedecisionregardingtheneedforastudyhasbeendetermined.NOTE:ThisformmayalsobeusedasaguideinmakingthedeterminationabouttheneedtoperformaPMCFS.5.2.6.TheProductRegulatoryAffairsRepr

30、esentativeshallcompletethePost-MarketClinicalFollow-UpPlan(AppendixB)thatdetailstheplanforpost-marketclinicalfollow-up.5.2.7.TheResearchManagerordesigneeandMedicalAffairsRepresentativeshallreviewthePost-MarketClinicalFollow-UpJustificationFormandThe文案大全6/19上市后临床追踪管理系统程序合用文档Post-MarketClinicalFollow-

31、UpPlantoconfirmthedecisionsregardingpost-marketclinicalmonitoring.5.3.NoPostMarketClinicalFollow-UpStudyRequired5.3.1.IfitwasdeterminedthatnoPMCFSisrequired(basedonsection5.2),post-marketclinicalmonitoringisstillrequiredforthemedicaldevice.5.3.2.JustificationregardingthedecisionnottoperformaPMCFSmus

32、tbeclearlydocumentedandmaintainedinthedesignhistory/technicalfile(see5.2.5).5.3.3.Post-MarketClinicalMonitoringRequirements(minimum).Ataminimum,thefollowingpost-marketclinicalmonitoringactivitiesshallbecompletedaccordingtoTDIFoot/AnkleArray8chestablishedprocedures/workinstructions.Theseelementswillb

33、einputsintothePost-MarketLiteratureEvaluationandMarketAnalysisReport.ReviewofproductcomplaintsaccordingtoComplaintHandlingProcedureReviewofpostmarketadverseeventsaccordingtoPostMarketEventReportingProcedureLiteraturereviewaccordingtoTDIFoot/AnkleArray8chEvaluationofClinicalDatatoSupportCEMarkingWork

34、Instruction.Reviewofproductcomplaints,postmarketadverseeventsandtheliteraturereviewshallbecompletedattheintervalsspecifiedinTable5-1.Thetimingoutlinedprovidestheminimumrequirements.TheProductRegulatoryAffairsRepresentativeand/ortheResearchManagerordesigneecandeterminethatclinicaldatashallbereviewedm

35、oreoften.Table5-1:TimingforReviewofClinicalDatabasedonMedicalDeviceClassDeviceClassificationTimingforreviewofclinicaldata(minimum)ClassIAnnuallyClassIIa,IIbAtaminimumannually,shouldconsidermoreoftenClassIIISemi-annually(i.e.twiceayear),shouldconsidermoreoften.AttheintervaloutlinedinTable5-1,theResea

36、rchManagerordesigneeshallcompletealiteraturereviewandanalysisofpost-marketexperiences(plaintsandadverseevents)andre-evaluateifa文案大全7/19上市后临床追踪管理系统程序合用文档PMCFSneedstobeconductedbasedonthisdata.ThePostMarketLiteratureEvaluationandMarketAnalysisConclusionform(AppendixD)shallbecompletedandmaintainedaspar

37、tofthedevicesdesignhistory/technicalfile.TheProductRegulatoryAffairsRepresentativeandMedicalAffairsRepresentativeshallreviewandapprovethisdocument.NOTE:TheliteraturereviewshallbeexecutedaccordingtotheEvaluationofClinicalDatatoSupportCEMarkingWorkInstruction,section5.5.However,thefollowingforms/templ

38、atesshallbeusedinplaceofthosespecifiedinthisworkinstruction:a.InsteadofusingTheLiteratureEvaluationPlantemplatereferenced,usethePostMarketLiteratureEvaluationandMarketExperiencePlanform(AppendixC)b.InsteadofusingTheLiteratureEvaluationReportandConclusiontemplate,usethePost-MarketLiteratureEvaluation

39、andMarketAnalysisReportandConclusionform(AppendixD)5.4.PostMarketClinicalFollow-UpStudyRequired5.4.1.IfitwasdeterminedthataPMCFSisrequired,inadditiontotherequirementslistedunder5.3.3,studiessuchasextendedfollow-upofpatientsenrolledinthepre-markettrials,prospectivestudyofarepresentativesubsetofpatien

40、tsafterthedeviceisplacedonthemarket,oranopenregistrymaybeperformed.5.4.2.ThePMCFSshallbecarriedoutinaccordancewithTDIFoot/AnkleArray8chsResearchInvolvingHumanSubjectsProcedure5.4.3.TheResearchManagerordesigneeinconsultationwiththeRegulatoryAffairsRepresentativeandtheDesignEngineeringand/orEngineerin

41、gRepresentativewilldeterminethetypeofPMCFSthatwillbeimplemented.5.4.4.Thestudyshouldtakeintoaccountthefollowing:ResultsoftheclinicalinvestigationincludingadverseeventsidentifiedAveragelifeexpectancyofthedeviceTheclaimsmadebythemanufacturerforthedevicePerformancesforwhichequivalenceisclaimedNewinform

42、ationbecomingavailable.AttheintervaloutlinedinTable5-1,theResearchManagerordesigneeshallcompletealiteraturereviewandanalysisofpost-marketexperiences(plaintsandadverseevents)andreviewtheongoingresults/dataofthePMCFS.ThePostMarketLiteratureEvaluationandMarketAnalysisConclusionform(AppendixD)shallbemai

43、ntainedaspart文案大全8/19上市后临床追踪管理系统程序合用文档ofthedevicesdesignhistory/technicalfile.TheProductRegulatoryAffairsRepresentativeandMedicalAffairsRepresentativeshallreviewandapprovethisdocument.NOTE:TheliteraturereviewshallbeexecutedaccordingtotheEvaluationofClinicalDatatoSupportCEMarkingWorkInstruction,secti

44、on5.5.However,thefollowingforms/templatesshallbeusedinplaceofthosespecifiedinthisworkinstruction:a.InsteadofusingTheLiteratureEvaluationPlantemplatereferenced,usethePostMarketLiteratureEvaluationandMarketExperiencePlanform(AppendixC)b.InsteadofusingTheLiteratureEvaluationReportandConclusiontemplate,

45、usethePost-MarketLiteratureEvaluationandMarketAnalysisReportandConclusionform(AppendixD)5.5.Elementsofapost-marketclinicalfollow-upstudy5.5.1.Post-marketclinicalfollow-upstudiesareperformedonadevicewithinitsintendeduse/purpose(s)accordingtotheinstructionsforuse.5.5.2.APMCFSshallincludetheelementsdef

46、inedintheWritingClinicalInvestigationalPlansandProtocolsWorkInstruction.5.5.3.Theobjective(s)ofaPMCFSshouldbestatedclearlyandshouldaddresstheresidualrisk(s)identified.Itshouldbeformulatedtoaddressoneormorespecificquestionsrelatingtotheclinicalsafetyorperformanceofthedevice.5.5.4.Post-marketclinicalf

47、ollow-upstudiesshouldbedesignedtoaddresstheobjective(s)ofthestudy.Thedesignmayvarybasedontheobjective(s)andshouldbescientificallysoundtoallowforvalidconclusionstobedrawn.5.5.5.Thestudydesigncantakeseveralforms,forexample:theextendedfollow-upofpatientsenrolledinpre-marketinvestigations;anewclinicalin

48、vestigation;areviewofdataderivedfromadeviceregistry;areviewofrelevantretrospectivedatafrompatientspreviouslyexposedtothedevice.theanalysisplanincludinganyinterimreporting;andproceduresforearlystudytermination.5.5.6.ThedataandconclusionsderivedfromthePMCFSareusedtoprovideclinicalevidencetosupportthep

49、ost-marketsurveillanceprogram.Thisprocessmayresultintheneedtoreassesswhetherthedevicecontinues文案大全9/19上市后临床追踪管理系统程序合用文档tocomplywiththeEssentialPrinciples.Suchassessmentsmayresultincorrectiveorpreventiveactions.6.APPENDIX6.1.AppendixA:Post-MarketClinicalFollow-UpStudyDeterminationXXXXXXXHealthcareXXX

50、XXXXDevice:Thisformisusedtodocumenttherationalefordeterminingtheneedforapost-marketclinicalfollow-upstudy.Oncecomplete,thisformshallbesavedaspartofthedevicestechnicalfile.Section1:DetermineiftheproposedequivalentdevicemeetstherequiremequivalenceasoutlinedinMEDDEV.2.7.1.Thereisnoproposedequivalentdev

51、ice(proceedtoSection2)Proposedequivalentdevicemanufacturer/devicename:Proposedequivalentdevicemodelnumber:文案大全10/19上市后临床追踪管理系统程序合用文档Questions1-10mustbeansweredyesorn/ainorderfortheproposedequivalentdevicetomeetthedefinitionofequivalent.ClinicalEquivalence:1.Istheproposedequivalentdeviceusedforthesam

52、eYesNoclinicalconditionorpurposeasthedevice?Explain:2.IstheproposedequivalentdeviceusedatthesamesiteYesNointhebodyasthedevice?Explain:3.IstheproposedequivalentdeviceusedinasimilarYesNopopulation(includingage,anatomy,physiology)astheXXXXXXXdevice?Explain:4.DoestheproposedequivalentdevicehavesimilarYe

53、sNorelevantcriticalperformanceaccordingtoexpectedclinicaleffectforaspecificintendeduseastheXXXXXXXdevice?Explain:TechnicalEquivalence:5.IstheproposedequivalentdeviceusedundersimilarYesNoconditionsofuseastheXXXXXXXproduct?Explain:6.DoestheproposedequivalentdevicehavesimilarYesNospecificationsandprope

54、rties(i.e.tensilestrength,viscosity,surfacecharacteristics)astheXXXXXXXdevice?Explain:7.IstheproposedequivalentdeviceofsimilardesignasYesNotheXXXXXXXdevice?Explain:8.DoestheproposedequivalentdevicehavesimilarYesNoprinciplesofoperationastheXXXXXXXdevice?Explain:9.Ifapplicable,doestheproposedequivalen

55、tdeviceuseYesNo文案大全11/19上市后临床追踪管理系统程序合用文档similardeploymentmethodsastheXXXXXXXdevice?N/AExplain:BiologicalEquivalence:10.Ifapplicable,doestheproposedequivalentdeviceuseYesNothesamematerialsincontactwiththesamehumanN/AtissueorbodyfluidsastheXXXXXXXdevice?Explain:Additional:11.Doestheproposedequivalent

56、devicerequireaYesNopost-marketclinicalfollow-upstudyaspartofitsregulatoryapproval?Explain:Section2:EvaluatetheresidualrisksAllthequestionsbelowrefertheXXXXXXXdevice.12.Isthedeviceinnovative(i.e.wherethedesignoftheYesNodevice,thematerials,theprinciplesofoperation,thetechnologyorthemedicalindicationar

57、enovel)?Ifapplicable,describe:Description:13.Doesthedevicetargetahigh-riskanatomicalsiteYesNo(i.e.,heart,centralnervoussystem)?Ifapplicable,identifysite:Anatomicalsite:14.DoesthedevicetargetaseverediseaseoradiseaseYesNothatposestreatmentchallenges?Description:15.Doesthedevicetargetasensitivetargetpo

58、pulationYesNo(i.e.,infants,children,pregnantwomen,etc.)?Ifapplicable,identifytargetpopulation:Targetpopulation:文案大全12/19上市后临床追踪管理系统程序合用文档16.Wasanacceptableriskidentifiedduringthepre-CEYesNoclinicalevaluationthatshouldbemonitoredinalongertermand/orinalargerpopulation?Ifapplicable,identifyrisk:Risks:1

59、7.Havewell-knownrisksbeenidentifiedinliteratureorYesNosimilarmarketdevices?Ifapplicable,identifyrisks:Risks:18.Wasthereadiscrepancybetweenthepre-marketYesNofollow-uptimescalesandtheexpectedlifeoftheproduct?Ifapplicable,describe:Description:19.DidtheXXXXXXXpost-developmentriskassessmentYesNoidentifya

60、nyrisksthatfellintotheunacceptablecategoryontheriskacceptabilitymatrix?Ifapplicable,identifyrisks:Unacceptablerisks:Section3:DeterminewhetheraPost-MarketClinicalFollow-UpStudyneedstobeperformed.APost-MarketClinicalFollow-UpStudy(PMCFS)shouldalwaysbeconsideredfordeviceswheretheidentificationofpossibl