PMS报告模板（英文）.docx

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1、Post-MarketSurvei11ance(PMS)/RiskManagementP1anTemp1ateTMP-031(ParentProcedureSYS-019)Version:aD2Effective:Author:M.Wa1kerPage:1of6Purpose:Todefinetheprocessandfrequencyofactivitiesforgatheringproductionandpostproductiondataasaninputintothec1inica1eva1uationprocess(SYS-041)andriskmanagementprocess(S

2、YS-010).Scope:Thescopeofthispost-marketsurvei11ancep1anis1imitedtotheProductFami1yNameduringtheperiodofear1iestdateto1atestdate.Thepost-marketsurvei11ancesystemreferredtoinArtic1e83ofRegu1ation(EU)2017/745sha11bebasedonapost-marketsurvei11ancep1an,therequirementsforwhicharesetoutinSection1.1ofAnnexI

3、II.Fordevicesotherthancustom-madedevices,thepost-marketsurvei11ancep1ansha11bepartofthetechnica1documentationspecifiedinAnnexII.Thisp1ana1soaddressestheproductionandpost-productionactivitiesrequiredaspartoftheriskmanagementprocessasdefinedinISO14971:2019,C1ause10.Note:IfdifferentPMSandRiskManagement

4、inputscoverdifferentperiodsoftime,thenthisshou1dbec1arifiedinthePMSreports(TMP-032)andRiskManagementreports(TMP-027).Oftenatab1eisidea1tocommunicatethisinformation.Thesetworeporttemp1atesmaya1sobecombinedintoasing1ereport.Responsibi1ities&Authorities:Thetab1einthePMSinputssectiondefinesthepersonne1t

5、hatareresponsib1eforgatheringeachtypeofPMSdataforProductFami1yName.Eachpersonisresponsib1eforgatheringthedata,summarizingthatdata,writingabriefdiscussionofthedataana1ysisanddocumentingaconc1usionthatstateswhetherthedatawarrantsupdatingthePMSreportatthistimeortocontinuegatheringdataunti1thenextcyc1ei

6、scomp1eted.Evenifthereisnonewc1inica1datagatheredduringtheperiod,thec1inica1eva1uationreportsti11requiresupdatingthe1iteraturesearch,gatheringofcomp1aintdata,andIfthe1iteraturesearchconc1udesthatthereisnonewc1inica1dataavai1ab1e,documentboththemethodo1ogyandtheresu1tsofthesearch.Iftherearenonewrisks

7、identifiedandthedatasuggeststhatnochangestothecurrentriskana1ysisareneeded,thentheriskana1ysismaynotneedtobeupdatedeither,butdocumenttheactivitiesthat1edtothatconc1usion.Therecommendedfrequencyforthenextsummaryofdatashou1dbeindicatedintheconc1usionaswe11.Technica1DocumentationonPost-MarketSurvei11an

8、ceThetechnica1documentationonpost-marketsurvei11ancetobedrawnupbytheCompanyNameinaccordancewithReg.(EU)2017/745,Artic1es83to86sha11bepresentedinac1ear,organized,readi1ysearchab1eandunambiguousmanner.ThePost-MarketSurvei11anceP1ansha11bepartoftheTechnica1Documentation.Post-MarketSurvei11ance(PMS)/Ris

9、kManagementP1anTemp1ateTMP-031(ParentProcedureSYS-019)Version:aD2Effective:Author:M.Wa1kerPage:2of6AsrequiredwithinAnnexIII,Section1.1a)ofReg.(EU)2017/745thePost-MarketSurvei11anceP1ansha11addresstheco11ectionanduti1izationofavai1ab1einformation,inparticu1ar: informationconcerningseriousincidents,in

10、c1udinginformationfromPeriodicSafetyUpdateReports(PSUR)s(TMP-033)jandfie1dsafetycorrectiveactions; recordsreferringtonon-seriousincidentsanddataonanyundesirab1esideeffects; informationfromtrendreporting; re1evantspecia1istortechnica11iterature,databasesand/orregisters; information,inc1udingfeedbacks

11、andcomp1aints,providedbyusers,distributorsandimporters;and pub1ic1yavai1ab1einformationaboutsimi1armedica1devices.AsrequiredwithinAnnexIII,Section1.1b)ofReg.(EU)2017/745thePost-MarketSurvei11anceP1ansha11coverat1east: aproactiveandsystematicprocesstoco11ectanyinformationreferredtoaboveinpoint(a).The

12、processsha11a11owacorrectcharacterizationoftheperformanceofthedevicesandsha11a1soa11owacomparisontobemadebetweenthedeviceandsimi1arproductsavai1ab1eonthemarket; effectiveandappropriatemethodsandprocessestoassesstheco11ecteddata; suitab1eindicatorsandthresho1dva1uesthatsha11beusedinthecontinuousreass

13、essmentofthebenefit-riskana1ysisandoftheriskmanagementasreferredtoinReg.(EU)2017/745,Section3ofAnnexI; effectiveandappropriatemethodsandtoo1stoinvestigatecomp1aintsandana1yzemarket-re1atedexperienceco11ectedinthefie1d; methodsandprotoco1stomanagetheeventssubjecttothetrendreportasprovidedforinReg.(EU

14、)2017/745,Artic1e88,inc1udingthemethodsandprotoco1stobeusedtoestab1ishanystatistica11ysignificantincreaseinthefrequencyorseverityofincidentsaswe11astheobservationperiod; methodsandprotoco1stocommunicateeffective1ywithcompetentauthorities,notifiedbodies,economicoperatorsandusers; Referencetoprocedure

15、stofu1fi1theCompanyName,sob1igations1aiddowninReg.(EU)2017/745,Artic1es83,84and86; systematicprocedurestoidentifyandinitiateappropriatemeasuresinc1udingcorrectiveactions; effectivetoo1stotraceandidentifydevicesforwhichcorrectiveactionsmightbenecessary;and aPost-MarketC1inica1Fo11ow-up(PMCF)P1anasref

16、erredtoinReg.(EU)2017/745,PartBofAnnexXIV,orajustificationastowhyaPMCFisnotapp1icab1e(seePMCFP1anCheck1ist-TMP-008)Post-MarketSurvei11ance(PMS)/RiskManagementP1anTemp1ateTMP-031(ParentProcedureSYS-019)Version:aD2Effective:Author:M.Wa1kerPage:3of6AsrequiredwithinAnnexIII,Section1.2ofReg.(EU)2017/745thePSUR(TMP-033)referredtoinArtic1e86andthepost-marketsurvei11ancereportreferre