上市后临床跟踪管理程序

上市后临床跟踪控制程序文件编号：QP-29版本：A/0生效日期：页码：17编制：审核：批准：1.PURPOSEThepurposeofthisworkinstructionistodefinetheprocesstodetermineanddocumentwhetherapost-marketclinicalfollow-upstudyisrequiredforTDIFoot/AnkleArray8chmedicaldevicesbearingtheCEmark.Theprocesswillleadtoadeterminationofwhetherapost-marketclinicalfollow-upstudyisrequiredandprovideguidanceforpost-marketclinicalmonitoringrequirementsifastudyisnotrequired.2.SCOPETheworkinstructionappliestoallmedicaldevicebusinessesandsitesoperatingundertheTDIFoot/AnkleArray8chHealthcareQualityManagementSystem.OnlymedicaldevicesbearingtheCEMarkwillberequiredtofollowthisworkinstruction.3.REFERENCES3.1.ExternalReferences3.1.1.LawsCouncilDirective93/42/EECof14June1993concerningmedicaldevicesincludingamendmentsthrough05September20073.1.2.GuidanceDocumentsEuropeanCommissionEnterprise-Directorate-GeneralMEDDEV2.12-2GuidelinesonPostMarketClinicalFollow-UpdatedMay2004MEDDEV2.7.1Rev.3guidelinesonmedicaldevice-clinicalevaluation-aguideformanufacturersandnotifiedbodiesdatedApril2009GHTFPost-MarketClinicalFollow-UpStudies;SG5(PD)N4R7(Proposeddocument23July2008)GHTFClinicalInvestigations;SG5(PD)N3R7(20January2008)4.ROLESANDRESPONSIBILITIESImportant:Whenatitleofapositionislistedinthisworkinstruction,itrelatestothatpositionoritsequivalent.Belowaretherolesandresponsibilitiesdiscussedwithinthisdocument.Table4-1:RolesandResponsibilitiesRoleResponsibilityDesignEngineeringand/orEngineeringRepresentativeProvideconsultationtotheProductRegulatoryAffairsRepresentativeindeterminingforagivenproject/productwhetherapost-marketclinicalfollow-upstudyisrequiredProvideconsultationtotheProductRegulatoryAffairsRepresentativetodetermineifanequivalentdeviceexistsProvideconsultationtotheProductRegulatoryAffairsRepresentativeinidentifyingemergingrisksforthemedicaldeviceProvideconsultationtotheResearchManagerordesigneetodeterminethetypeofpost-marketclinicalfollow-upstudytobeimplemented,ifapplicableProductRegulatoryAffairsRepresentativeDetermineforagiveproject/productwhetherapost-marketclinicalfollow-upstudyisrequiredDetermineifanequivalentdeviceexistsIdentifypotentialemergingrisksReviewriskassessmentCompletethePost-MarketClinicalFollow-UpJustificationFormregardingdecisiontoperformastudyCompletethePost-MarketClinicalFollow-UpPlanformthatdetailsthepost-marketclinicalfollow-upplanDeterminehowoftenclinicaldatamustbereviewedReviewandapprovetheclinicalevaluationperformedbytheResearchManagerordesigneeRegulatoryAffairsRepresentativeProvideconsultationtotheResearchManagertodeterminethetypeofpost-marketclinicalfollow-upstudytobeimplemented,ifapplicableTable4-1:RolesandResponsibilitiesRoleResponsibilityResearchManagerordesigneeProvideconsultationtotheProductRegulatoryAffairsRepresentativeindeterminingforagivenproject/productwhetherapost-marketclinicalfollow-upstudyisrequiredProvideconsultationtotheProductRegulatoryAffairsRepresentativetodetermineifanequivalentdeviceexistsProvideconsultationtotheProductRegulatoryAffairsRepresentativetoidentifypotentialemergingrisksReviewthePost-MarketClinicalFollow-UpJustificationformandPost-MarketClinicalFollow-UpPlanformtoconfirmthedecisionsregardingtheneedforapost-marketclinicalfollow-upstudyandclinicalfollow-upDeterminehowoftenclinicaldatamustbereviewedDeterminethetypeofpost-marketclinicalfollow-upstudytobeimplemented,ifapplicableReviewnewdata(i.e.literature,adverseevents,complaints,etc,)anddetermineifapost-marketclinicalfollow-upstudyisnecessarybasedonnewinformation(clinicalevaluation)MedicalAffairsRepresentativeReviewthePost-MarketClinicalFollow-UpJustificationformandPost-MarketClinicalFollow-UpPlanformtoconfirmthedecisionsregardingtheneedforapost-marketclinicalfollow-upstudyandclinicalfollow-upReviewandapprovetheclinicalevaluationperformedbytheResearchManagerordesignee5.WORKINSTRUCTIONPost-marketclinicalmonitoringisanessentialelementinestablishinglongtermsafetyfollow-updataandpossibleemergentrisksformedicaldevices.Theserisksanddatacannotadequatelybedetectedandcharacterizedbyrelyingsolelyonpre-marketclinicalinvestigations.Postmarketclinicalmonitoringmayincludeacombinationofseveralstrategies:ProductcomplaintreviewPost-marketeventreportingreviewofusersandpatientsLiteraturereviewPost-marketclinicalfollow-upstudies(PMCFS)ThisworkinstructionwascreatedtodeterminewhenaPMCFSisnecessarytomaintainanadequatepost-marketsurveillancesystem,asrequiredbytheMedicalDeviceDirective93/42/ECC(MDD)asamendedbyMDD2007/47/EC.Itwillalsoprovideguidanceonthepost-marketclinicalmonitoringrequirementsifaPMCFSisnotrequired.Figure5-1:High-LevelProcessOverviewforPost-MarketClinicalFollow-UpDeterminewhetheranequivalentdeviceexistsIdentifyresidualrisks/emergingrisksReviewRiskAssessmentdocumentEvaluateneedforPMCFSPMCFSRequired?PMCFSDeterminationPerformPMCFSinaccordancewithGEHC_GQP_10.03andGEHC_GQP_10.03.002YESAtaminimum,reviewclinicaldataincluding,AE抯,complaintsandliteratureNOReviewnewdataanddeterminetheneedtoaPMCFSbasedonnewinformation5.1.GeneralRequirements5.1.1.PriortoM3sign-off,theProductReg