PMS报告模板(英文).docx
- 文档编号:26875145
- 上传时间:2023-06-23
- 格式:DOCX
- 页数:6
- 大小:22.92KB
PMS报告模板(英文).docx
《PMS报告模板(英文).docx》由会员分享,可在线阅读,更多相关《PMS报告模板(英文).docx(6页珍藏版)》请在冰豆网上搜索。
Post-MarketSurveillance(PMS)/RiskManagementPlanTemplateTMP-031(ParentProcedureSYS-019)
Version:
aD2
Effective:
Author:
M.Walker
Page:
1of6
Purpose:
Todefinetheprocessandfrequencyofactivitiesforgatheringproductionandpostproductiondataasaninputintotheclinicalevaluationprocess(SYS-041)andriskmanagementprocess(SYS-010).
Scope:
Thescopeofthispost-marketsurveillanceplanislimitedtothe[ProductFamilyName]duringtheperiodof[earliestdate]to[latestdate].Thepost-marketsurveillancesystemreferredtoinArticle83ofRegulation(EU)2017/745shallbebasedonapost-marketsurveillanceplan,therequirementsforwhicharesetoutinSection1.1ofAnnexIII.Fordevicesotherthancustom-madedevices,thepost-marketsurveillanceplanshallbepartofthetechnicaldocumentationspecifiedinAnnexII.Thisplanalsoaddressestheproductionandpost-productionactivitiesrequiredaspartoftheriskmanagementprocessasdefinedinISO14971:
2019,Clause10.
Note:
IfdifferentPMSandRiskManagementinputscoverdifferentperiodsoftime,thenthisshouldbeclarifiedinthePMSreports(TMP-032)andRiskManagementreports(TMP-027).Oftenatableisidealtocommunicatethisinformation.Thesetworeporttemplatesmayalsobecombinedintoasinglereport.
Responsibilities&Authorities:
ThetableinthePMSinputssectiondefinesthepersonnelthatareresponsibleforgatheringeachtypeofPMSdatafor[ProductFamilyName].Eachpersonisresponsibleforgatheringthedata,summarizingthatdata,writingabriefdiscussionofthedataanalysisanddocumentingaconclusionthatstateswhetherthedatawarrantsupdatingthePMSreportatthistimeortocontinuegatheringdatauntilthenextcycleiscompleted.Evenifthereisnonewclinicaldatagatheredduringtheperiod,theclinicalevaluationreportstillrequiresupdatingtheliteraturesearch,gatheringofcomplaintdata,andIftheliteraturesearchconcludesthatthereisnonewclinicaldataavailable,documentboththemethodologyandtheresultsofthesearch.Iftherearenonewrisksidentifiedandthedatasuggeststhatnochangestothecurrentriskanalysisareneeded,thentheriskanalysismaynotneedtobeupdatedeither,butdocumenttheactivitiesthatledtothatconclusion.Therecommendedfrequencyforthenextsummaryofdatashouldbeindicatedintheconclusionaswell.
TechnicalDocumentationonPost-MarketSurveillance
Thetechnicaldocumentationonpost-marketsurveillancetobedrawnupbythe[CompanyName]inaccordancewithReg.(EU)2017/745,Articles83to86shallbepresentedinaclear,organized,readilysearchableandunambiguousmanner.ThePost-MarketSurveillancePlanshallbepartoftheTechnicalDocumentation.
Post-MarketSurveillance(PMS)1RiskManagementPlanTemplateTMP-031(ParentProcedureSYS-019)
Version:
aD2
Effective:
Author:
M.Walker
Page:
2of6
AsrequiredwithinAnnexIII,Section1.1a)ofReg.(EU)2017/745thePost-MarketSurveillancePlanshalladdressthecollectionandutilizationofavailableinformation,inparticular:
•informationconcerningseriousincidents,includinginformationfromPeriodicSafetyUpdateReports(PSUR)s(TMP-033),andfieldsafetycorrectiveactions;
•recordsreferringtonon-seriousincidentsanddataonanyundesirablesideeffects;
•informationfromtrendreporting;
•relevantspecialistortechnicalliterature,databasesand/orregisters;
•information,includingfeedbacksandcomplaints,providedbyusers,distributorsandimporters;and
•publiclyavailableinformationaboutsimilarmedicaldevices.
AsrequiredwithinAnnexIII,Section1.1b)ofReg.(EU)2017/745thePost-MarketSurveillancePlanshallcoveratleast:
•aproactiveandsystematicprocesstocollectanyinformationreferredtoaboveinpoint(a).Theprocessshallallowacorrectcharacterizationoftheperformanceofthedevicesandshallalsoallowacomparisontobemadebetweenthedeviceandsimilarproductsavailableonthemarket;
•effectiveandappropriatemethodsandprocessestoassessthecollecteddata;
•suitableindicatorsandthresholdvaluesthatshallbeusedinthecontinuousreassessmentofthebenefit-riskanalysisandoftheriskmanagementasreferredtoinReg.(EU)2017/745,Section3ofAnnexI;
•effectiveandappropriatemethodsandtoolstoinvestigatecomplaintsandanalyzemarket-relatedexperiencecollectedinthefield;
•methodsandprotocolstomanagetheeventssubjecttothetrendreportasprovidedforinReg.(EU)2017/745,Article88,includingthemethodsandprotocolstobeusedtoestablishanystatisticallysignificantincreaseinthefrequencyorseverityofincidentsaswellastheobservationperiod;
•methodsandprotocolstocommunicateeffectivelywithcompetentauthorities,notifiedbodies,economicoperatorsandusers;
•Referencetoprocedurestofulfilthe[CompanyName]’sobligationslaiddowninReg.(EU)2017/745,Articles83,84and86;
•systematicprocedurestoidentifyandinitiateappropriatemeasuresincludingcorrectiveactions;
•effectivetoolstotraceandidentifydevicesforwhichcorrectiveactionsmightbenecessary;and
•aPost-MarketClinicalFollow-up(PMCF)PlanasreferredtoinReg.(EU)2017/745,PartBofAnnexXIV,orajustificationastowhyaPMCFisnot
applicable(seePMCFPlanChecklist-TMP-008)
TK*Q]
Post-MarketSurveillance(PMS)/RiskManagementPlanTemplateTMP-031(ParentProcedureSYS-019)
Version:
aD2
Effective:
Author:
M.Walker
Page:
3of6
AsrequiredwithinAnnexIII,Section1.2ofReg.(EU)2017/745thePSUR(TMP-033)referredtoinArticle86andthepost-marketsurveillancereportreferredtoinArticle85shallalsobeincluded.
AsrequiredbyISO14971:
2019,Clause10,[CompanyName]shallcollect,whereapplicable:
a)informationgeneratedduringproductionandmonitoringoftheproductionprocess;
b)informationgeneratedbytheuser;
c)informationgeneratedbythoseaccountablefortheinstallation,useandmaintenanceofthemedicaldevice;
d)informationgeneratedbythesupplychain;
e)publiclyavailableinformation;and
f)informationrelatedtothegenerallyacknowledged“stateoftheart."
[CompanyName]shallalsoconsidertheneedtoactivelycollectandreviewpubliclyavailableinformationaboutsimilarmedicaldevicesandsimilarotherproductsonthemarket.
PMS&RiskManagementInputs:
ThefollowingtableidentifiesthePMSReportInputsfor[ProductFamilyName].
Item#
DescriptionofInput
Responsible
Person
FrequencyofReview
1
InformationfromR&D(mayincludecontractdesignfirm)
DesignTeamLeaders
Atdesignphasereviews
2
ServicedataasperSYS-013(individualservicerecordsandstatisticalanalysisinaccordancewith21CFR820.200&ISO13485:
2016,Clause
7.5.4)
Service
Manager
Monthly
3
ComplaintdataasperSYS-018(individualcomplaintrecordsandtrendanalysisofcomplaintsasper21CFR820.198&ISO13485:
2016,Clause8.2.2)
Complaint
HandlingUnit
Monthly
4
CustomerFeedbackSurveysasperSYS-019including:
•informationgeneratedbytheuser
•informationgeneratedbythoseaccountablefortheinstallation,useandmaintenanceofthemedicaldevice
Customer
Service
Quarterly
Post-MarketSurveillance(PMS)/RiskManagementPlanTemplateTMP-031(ParentProcedureSYS-019)
Version:
aD2
Effective:
Author:
M.Walker
Page:
4of6
5
AdverseEventDatabases(e.g.,MAUDE)
Regulatory
Affairs
Quarterly
6
ClinicalLiteratureReviewasperSYS-041(i.e.,periodicexecutionofliteraturesearchprotocol)
•informationrelatedtothegenerallyacknowledged“stateoftheart”
•informationaboutsimilarmedicaldevicesandsimilarotherproductsonthemarket.
ClinicalAffairs
Quarterly
7
New&RevisedRegulatoryRequirements,ExternalStandards,CommonSpecifications,andGuidanceDocuments
Regulatory
Affairs
ManagementReviewOutput
8
Drug-relatedinformation(ifapplicable)
Clinical
Affairs
Quarterly
9
Own-BrandLabeledPMS(ifapplicable)
QualityAssurance
Quarterly
10
Salesforce,Distributor,TradeshowFeedback,andotherpubliclyavailableinformation
Sales
Quarterly
11
Informationgeneratedduringproductionandmonitoringoftheproductionprocess
Production
Monthly
12
Informationgeneratedbythesupplychain
SupplyChain
Monthly
DataSummary:
EachpersonresponsibleforgatheringPMSdatashallsummarizethedataonthefrequencyidentifiedinthetableabove.Ifthereisnonewdatatoreport,thisshouldbestatedinthesummary.Ifthereisalargeamountofsimilardata,itisacceptabletopresentastatisticalanalysisofthatdata(refertoSYS-022,StatisticalTechniques).
ReviewofInformation:
[CompanyName]shallreviewtheinformationcollectedforpossiblerelevancetosafety,especiallywhether:
—previouslyunrecognizedhazardsorhazardoussituationsarepresent;
—anestimatedriskarisingfromahazardoussituationisnolongeracceptable;
—theoverallresidualriskisnolongeracceptableinrelationtothebenefitsoftheintendeduse;or
—thegenerallyacknowledged“stateoftheart"haschanged.
Theresultsofthereviewshallberecordedintheriskmanagementfile,byupdatingtheriskmanagementreport(TMP-027).
Post-MarketSurveillance(PMS)/RiskManagementPlanTemplateTMP-031(ParentProcedureSYS-019)
Version:
aD2
Effective:
Author:
M.Walker
Page:
5of6
Complianceischeckedbyinspectionoftheriskmanagementfile.
DiscussionofData:
Ifthedatagatheredissimilartopreviousdatagathered,thenthisshouldbestatedinthediscussion.Ifthereisnewdata,theseverityofharmcausedbydevicemalfunctionchangesorifthefrequencyofincidentschangethisshou
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- PMS 报告 模板 英文
![提示](https://static.bdocx.com/images/bang_tan.gif)