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1、Post-MarketSurveillance(PMS)/RiskManagementPlanTemplateTMP-031(ParentProcedureSYS-019)Version:aD2Effective:Author:M.WalkerPage:1of6Purpose:Todefinetheprocessandfrequencyofactivitiesforgatheringproductionandpostproductiondataasaninputintotheclinicalevaluationprocess(SYS-041)andriskmanagementprocess(S
2、YS-010).Scope:Thescopeofthispost-marketsurveillanceplanislimitedtotheProductFamilyNameduringtheperiodofearliestdatetolatestdate.Thepost-marketsurveillancesystemreferredtoinArticle83ofRegulation(EU)2017/745shallbebasedonapost-marketsurveillanceplan,therequirementsforwhicharesetoutinSection1.1ofAnnexI
3、II.Fordevicesotherthancustom-madedevices,thepost-marketsurveillanceplanshallbepartofthetechnicaldocumentationspecifiedinAnnexII.Thisplanalsoaddressestheproductionandpost-productionactivitiesrequiredaspartoftheriskmanagementprocessasdefinedinISO14971:2019,Clause10.Note:IfdifferentPMSandRiskManagement
4、inputscoverdifferentperiodsoftime,thenthisshouldbeclarifiedinthePMSreports(TMP-032)andRiskManagementreports(TMP-027).Oftenatableisidealtocommunicatethisinformation.Thesetworeporttemplatesmayalsobecombinedintoasinglereport.Responsibilities&Authorities:ThetableinthePMSinputssectiondefinesthepersonnelt
5、hatareresponsibleforgatheringeachtypeofPMSdataforProductFamilyName.Eachpersonisresponsibleforgatheringthedata,summarizingthatdata,writingabriefdiscussionofthedataanalysisanddocumentingaconclusionthatstateswhetherthedatawarrantsupdatingthePMSreportatthistimeortocontinuegatheringdatauntilthenextcyclei
6、scompleted.Evenifthereisnonewclinicaldatagatheredduringtheperiod,theclinicalevaluationreportstillrequiresupdatingtheliteraturesearch,gatheringofcomplaintdata,andIftheliteraturesearchconcludesthatthereisnonewclinicaldataavailable,documentboththemethodologyandtheresultsofthesearch.Iftherearenonewrisks
7、identifiedandthedatasuggeststhatnochangestothecurrentriskanalysisareneeded,thentheriskanalysismaynotneedtobeupdatedeither,butdocumenttheactivitiesthatledtothatconclusion.Therecommendedfrequencyforthenextsummaryofdatashouldbeindicatedintheconclusionaswell.TechnicalDocumentationonPost-MarketSurveillan
8、ceThetechnicaldocumentationonpost-marketsurveillancetobedrawnupbytheCompanyNameinaccordancewithReg.(EU)2017/745,Articles83to86shallbepresentedinaclear,organized,readilysearchableandunambiguousmanner.ThePost-MarketSurveillancePlanshallbepartoftheTechnicalDocumentation.Post-MarketSurveillance(PMS)/Ris
9、kManagementPlanTemplateTMP-031(ParentProcedureSYS-019)Version:aD2Effective:Author:M.WalkerPage:2of6AsrequiredwithinAnnexIII,Section1.1a)ofReg.(EU)2017/745thePost-MarketSurveillancePlanshalladdressthecollectionandutilizationofavailableinformation,inparticular: informationconcerningseriousincidents,in
10、cludinginformationfromPeriodicSafetyUpdateReports(PSUR)s(TMP-033)jandfieldsafetycorrectiveactions; recordsreferringtonon-seriousincidentsanddataonanyundesirablesideeffects; informationfromtrendreporting; relevantspecialistortechnicalliterature,databasesand/orregisters; information,includingfeedbacks
11、andcomplaints,providedbyusers,distributorsandimporters;and publiclyavailableinformationaboutsimilarmedicaldevices.AsrequiredwithinAnnexIII,Section1.1b)ofReg.(EU)2017/745thePost-MarketSurveillancePlanshallcoveratleast: aproactiveandsystematicprocesstocollectanyinformationreferredtoaboveinpoint(a).The
12、processshallallowacorrectcharacterizationoftheperformanceofthedevicesandshallalsoallowacomparisontobemadebetweenthedeviceandsimilarproductsavailableonthemarket; effectiveandappropriatemethodsandprocessestoassessthecollecteddata; suitableindicatorsandthresholdvaluesthatshallbeusedinthecontinuousreass
13、essmentofthebenefit-riskanalysisandoftheriskmanagementasreferredtoinReg.(EU)2017/745,Section3ofAnnexI; effectiveandappropriatemethodsandtoolstoinvestigatecomplaintsandanalyzemarket-relatedexperiencecollectedinthefield; methodsandprotocolstomanagetheeventssubjecttothetrendreportasprovidedforinReg.(EU
14、)2017/745,Article88,includingthemethodsandprotocolstobeusedtoestablishanystatisticallysignificantincreaseinthefrequencyorseverityofincidentsaswellastheobservationperiod; methodsandprotocolstocommunicateeffectivelywithcompetentauthorities,notifiedbodies,economicoperatorsandusers; Referencetoprocedure
15、stofulfiltheCompanyName,sobligationslaiddowninReg.(EU)2017/745,Articles83,84and86; systematicprocedurestoidentifyandinitiateappropriatemeasuresincludingcorrectiveactions; effectivetoolstotraceandidentifydevicesforwhichcorrectiveactionsmightbenecessary;and aPost-MarketClinicalFollow-up(PMCF)Planasref
16、erredtoinReg.(EU)2017/745,PartBofAnnexXIV,orajustificationastowhyaPMCFisnotapplicable(seePMCFPlanChecklist-TMP-008)Post-MarketSurveillance(PMS)/RiskManagementPlanTemplateTMP-031(ParentProcedureSYS-019)Version:aD2Effective:Author:M.WalkerPage:3of6AsrequiredwithinAnnexIII,Section1.2ofReg.(EU)2017/745thePSUR(TMP-033)referredtoinArticle86andthepost-marketsurveillancereportreferre
