上市后临床跟踪管理程序.docx
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上市后临床跟踪管理程序.docx
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上市后临床跟踪管理程序
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
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A/0
生效日期:
页码:
19
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批准:
1.Purpose
Thepurposeofthisworkinstructionistodefinetheprocesstodetermineanddocumentwhetherapost-marketclinicalfollow-upstudyisrequiredforTDIFoot/AnkleArray8chmedicaldevicesbearingtheCEmark.Theprocesswillleadtoadeterminationofwhetherapost-marketclinicalfollow-upstudyisrequiredandprovideguidanceforpost-marketclinicalmonitoringrequirementsifastudyisnotrequired.
2.Scope
TheworkinstructionappliestoallmedicaldevicebusinessesandsitesoperatingundertheTDIFoot/AnkleArray8chHealthcareQualityManagementSystem.
OnlymedicaldevicesbearingtheCEMarkwillberequiredtofollowthisworkinstruction.
3.References
3.1.ExternalReferences
3.1.1.Laws
▪CouncilDirective93/42/EECof14June1993concerningmedicaldevicesincludingamendmentsthrough05September2007
3.1.2.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)
ResearchManagerordesignee
∙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
∙ReviewandapprovetheclinicalevaluationperformedbytheResearchManagerordesignee
4.WorkInstruction
Post-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-Up
4.1.GeneralRequirements
4.1.1.PriortoM3sign-off,theProductRegulatoryAffairsRepresentativeinconsultationwiththeResearchManagerordesigneeandtheDesignEngineeringand/orEngineeringRepresentativeshalldetermineforagivenproject/programwhetheraPMCFSisrequired.Theyshallalsodeterminethepost-marketclinicalfollow-upplan.
4.1.2.APMCFSmaynotberequiredforproductsforwhichmedium/long-termclinicalperformanceandsafetyisalreadyknownfromprevioususeofthedeviceorwhereotherappropriatepost-marketsurveillanceactivitieswouldprovidesufficientdatatoaddresstherisks.
4.2.DeterminingtheTypeofPost-MarketClinicalFollow-UpRequired
Post-marketclinicalmonitoringshallhaveoneoftwooutcomes,
(1)PMCFSrequiredor
(2)noPMCFSrequired.
TheneedforaPMCFSshallbebasedonacombinationofseveralfactorsdetailedinthissection.
4.2.1.TheProductRegulatoryAffairsRepresentativeinconsultationwiththeResearchManagerordesigneeandDesignEngineeringand/orEngineeringRepresentativeshalldeterminewhetheranequivalentdeviceexists.Equivalenceshallbedemonstratedinalltheessentialcharacteristicspreciselydefinedbelow.Equivalencemeans:
▪Clinical
▪Usedforthesameclinicalconditionorpurpose;
▪Usedatthesamesiteinthebody;
▪Usedinsimilarpopulation(includingage,anatomy,physiology);
▪Havesimilarrelevantcriticalperformanceaccordingtoexpectedclinicaleffectforspecificintendeduse
▪Technical
▪Usedundersimilarconditionsofuse;
▪Havesimilarspecificationsandproperties;
▪Beofsimilardesign;
▪Usesimilardeploymentmethods
▪Havesimilarprinciplesofoperation
▪Biological
▪Sameorsimilaruseofmaterialsincontactwithhumantissuesorbodyfluids
4.2.2.Productsforwhichthemedium/longtermclinicalperformanceandsafetyisalreadyknownfromprevioususeofthedevice,orfromfullytransferableexperiencewithequivalentdevicesshallnotrequireaPMCFS.
NOTE:
Ifthedevicequotedasthe“equivalent”requiresaPMCFS,thenthenewproductshallbesubjecttothesamerequirement.
4.2.3.TheneedforaPMCFSshallbedeterminedbasedontheidentificationofresidualrisksthatmayimpacttherisk/benefitratio.Astudyshouldalwaysbeconsideredfordeviceswheretheidentificationofpossibleemergingrisksandtheevaluationoflongtermsafetyandperformanceareessential.TheProductRegulatoryAffairsRepresentativeinconsultationwiththeResearchManagerordesigneeandDesignEngineeringand/orEngineeringRepresentativeshallidentifysuchemergingrisk,thefollowingcriteriashouldbetakenintoaccount:
▪innovation,e.g.,wherethedesignofthedevice,thematerials,theprinciplesofoperation,thetechnologyorthemedicalindicationsarenovel;
▪highriskanatomicallocations(i.e.,heart,centralnervoussystem,etc.);
▪severityofdisease/treatmentchallenges;
▪sensitivityoftargetpopulation(i.e.,infants,children,pregnantwomen,etc.);
▪identificationofanacceptableriskduringthepre-CEclinicalevaluation,whichshouldbemonitoredinalongertermand/orthroughalargerpopulation;
▪wellknownrisksidentifiedfromtheliteratureorsimilarmarketeddevices;
▪discrepancybetweenthepre-marketfollow-uptimescalesandtheexpectedlifeoftheproduct;
4.2.4.Aproperlyconductedriskanalysisisessentialindeterminingwhatclinicalevidencemaybeneededforaparticulardevice.Anyrisksidentifiedasan“unacceptable”riskattheconclusionofthedevelopmentprocessshallrequireaPMCFS.Astudyshouldalsobeconsideredforrisksidentifiedas“acceptable”or“riskmitigationrequired”ifthedevicemeetsanyoftheothercharacteristicsidentifiedin5.2.1and5.2.2.TheriskassessmentshallbeperformedaccordingtotheRiskManagementProcedure.TheProductRegulatoryAffairsRepresentativeshallreviewtheriskassessment.
4.2.5.TheProductRegulatoryAffairsRepresentativeshallcompletethePostMarketClinicalFollow-UpStudyDeterminationForm(AppendixA)oncethedecisionregardingtheneedforastudyhasbeendetermined.
1NOTE:
ThisformmayalsobeusedasaguideinmakingthedeterminationabouttheneedtoperformaPMCFS.
4.2.6.TheProductRegulatoryAffairsRepresentativeshallcompletethePost-MarketClinicalFollow-UpPlan(AppendixB)thatdetailstheplanforpost-marketclinicalfollow-up.
4.2.7.TheResearchManagerordesigneeandMedicalAffairsRepresentativeshallreviewthePost-MarketClinicalFollow-UpJustificationFormandThePost-MarketClinicalFollow-UpPlantoconfirmthedecisionsregardingpost-marketclinicalmonitoring.
4.3.NoPostMarketClinicalFollow-UpStudyRequired
4.3.1.IfitwasdeterminedthatnoPMCFSisrequired(basedonsection5.2),post-marketclinicalmonitoringisstillrequiredforthemedicaldevice.
4.3.2.JustificationregardingthedecisionnottoperformaPMCFSmustbeclearlydocumentedandmaintainedinthedesignhistory/technicalfile(see5.2.5).
4.3.3.Post-MarketClinicalMonitoringRequirements(minimum)
4.3.3.1.Ataminimum,thefollowingpost-marketclinicalmonitoringactivitiesshallbecompletedaccordingtoTDIFoot/AnkleArray8chestablishedprocedures/workinstructions.TheseelementswillbeinputsintothePost-MarketLiteratureEvaluationandMarketAnalysisReport.
▪ReviewofproductcomplaintsaccordingtoComplaintHandlingProcedure
▪ReviewofpostmarketadverseeventsaccordingtoPostMarketEventReportingProcedure
▪LiteraturereviewaccordingtoTDIFoot/AnkleArray8chEvaluationofClinicalDatatoSupportCEMarkingWorkInstruction.
4.3.3.2.Reviewofproductcomplaints,postmarketadverseeventsandtheliteraturereviewshallbecompletedattheintervalsspecifiedinTable5-1.Thetimingoutlinedprovidestheminimumrequirements.TheProductRegulatoryAffairsRepresentativeand/ortheResearchManagerordesigneecandeterminethatclinicaldatashallbereviewedmoreoften.
Table5-1:
TimingforReviewofClinicalDatabasedonMedicalDeviceClass
DeviceClassification
Timingforreviewofclinicaldata(minimum)
ClassI
Annually
ClassIIa,IIb
Ataminimumannually,shouldconsidermoreoften
Class
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- 上市 临床 跟踪 管理程序
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