上市后臨床跟蹤管理系統(tǒng)程序

1、上市后臨床追蹤管理系統(tǒng)程序合用文檔上市后臨床追蹤控制程序文件編號(hào)：QP-29版本：A/0見(jiàn)效日期：頁(yè)碼：19編制：審察：贊同：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上市后臨床追蹤管理系統(tǒng)程序合用文檔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上市后臨床追蹤管理系統(tǒng)程序合用文檔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上市后臨床追蹤管理系統(tǒng)程序合用文檔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上市后臨床追蹤管理系統(tǒng)程序合用文檔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上市后臨床追蹤管理系統(tǒng)程序合用文檔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上市后臨床追蹤管理系統(tǒng)程序合用文檔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上市后臨床追蹤管理系統(tǒng)程序合用文檔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上市后臨床追蹤管理系統(tǒng)程序合用文檔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上市后臨床追蹤管理系統(tǒng)程序合用文檔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上市后臨床追蹤管理系統(tǒng)程序合用文檔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上市后臨床追蹤管理系統(tǒng)程序合用文檔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上市后臨床追蹤管理系統(tǒng)程序合用文檔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