上市后临床跟踪管理程序

1、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/A。

2、nkleArray8chHealthcareQualityManagementSystem.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-aguideformanufacturersandnotifiedb。

3、odiesdatedApril2009GHTFPost-MarketClinicalFollow-UpStudies;SG5(PD)N4R7(Proposeddocument23July2008)GHTFClinicalInvestigations;SG5(PD)N3R7(20January2008)4.ROLESANDRESPONSIBILITIESImportant:Whenatitleofapositionislistedinthisworkinstruction,itrelatestothatpositionoritsequivalent.Belowaretherolesandresponsibilitiesdiscussedwithinthisdocument.Table4-1:RolesandResponsibilitiesRoleResponsibilityDesignEngineeringand/orEngineeringRepresentativeProvideconsultationtotheProductRegulatoryAffairsRepresenta。

4、tiveindeterminingforagivenproject/productwhetherapost-marketclinicalfollow-upstudyisrequiredProvideconsultationtotheProductRegulatoryAffairsRepresentativetodetermineifanequivalentdeviceexistsProvideconsultationtotheProductRegulatoryAffairsRepresentativeinidentifyingemergingrisksforthemedicaldeviceProvideconsultationtotheResearchManagerordesigneetodeterminethetypeofpost-marketclinicalfollow-upstudytobeimplemented,ifapplicableProductRegulatoryAffairsRepresentativeDetermineforagiveproject/produ。

5、ctwhetherapost-marketclinicalfollow-upstudyisrequiredDetermineifanequivalentdeviceexistsIdentifypotentialemergingrisksReviewriskassessmentCompletethePost-MarketClinicalFollow-UpJustificationFormregardingdecisiontoperformastudyCompletethePost-MarketClinicalFollow-UpPlanformthatdetailsthepost-marketclinicalfollow-upplanDeterminehowoftenclinicaldatamustbereviewedReviewandapprovetheclinicalevaluationperformedbytheResearchManagerordesigneeRegulatoryAffairsRepresentativeProvideconsultationtoth。

6、eResearchManagertodeterminethetypeofpost-marketclinicalfollow-upstudytobeimplemented,ifapplicableTable4-1:RolesandResponsibilitiesRoleResponsibilityResearchManagerordesigneeProvideconsultationtotheProductRegulatoryAffairsRepresentativeindeterminingforagivenproject/productwhetherapost-marketclinicalfollow-upstudyisrequiredProvideconsultationtotheProductRegulatoryAffairsRepresentativetodetermineifanequivalentdeviceexistsProvideconsultationtotheProductRegulatoryAffairsRepresentativetoidentifypot。

7、entialemergingrisksReviewthePost-MarketClinicalFollow-UpJustificationformandPost-MarketClinicalFollow-UpPlanformtoconfirmthedecisionsregardingtheneedforapost-marketclinicalfollow-upstudyandclinicalfollow-upDeterminehowoftenclinicaldatamustbereviewedDeterminethetypeofpost-marketclinicalfollow-upstudytobeimplemented,ifapplicableReviewnewdata(i.e.literature,adverseevents,complaints,etc,)anddetermineifapost-marketclinicalfollow-upstudyisnecessarybasedonnewinformation(clinicalevaluation)MedicalAf。

8、fairsRepresentativeReviewthePost-MarketClinicalFollow-UpJustificationformandPost-MarketClinicalFollow-UpPlanformtoconfirmthedecisionsregardingtheneedforapost-marketclinicalfollow-upstudyandclinicalfollow-upReviewandapprovetheclinicalevaluationperformedbytheResearchManagerordesignee5.WORKINSTRUCTIONPost-marketclinicalmonitoringisanessentialelementinestablishinglongtermsafetyfollow-updataandpossibleemergentrisksformedicaldevices.Theserisksanddatacannotadequatelybedetectedandcharacterizedbyrelyin。

9、gsolelyonpre-marketclinicalinvestigations.Postmarketclinicalmonitoringmayincludeacombinationofseveralstrategies:ProductcomplaintreviewPost-marketeventreportingreviewofusersandpatientsLiteraturereviewPost-marketclinicalfollow-upstudies(PMCFS)ThisworkinstructionwascreatedtodeterminewhenaPMCFSisnecessarytomaintainanadequatepost-marketsurveillancesystem,asrequiredbytheMedicalDeviceDirective93/42/ECC(MDD)asamendedbyMDD2007/47/EC.Itwillalsoprovideguidanceonthepost-marketclinicalmonitoringrequireme。

10、ntsifaPMCFSisnotrequired.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。