上市后临床跟踪管理系统程序.docx

上市后临床跟踪管理系统程序.docx

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上市后临床跟踪管理系统程序

上市后临床跟踪控制程序

文件编号：

QP-29

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A/0

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3

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批准：

1.Purpose

Thepurposeofthisworkinstructionistodefinetheprocesstodetermineanddocumentwhetherapost-marketclinicalfollow-upstudyisrequiredforTDIFoot/AnkleArray8chmedicaldevicesbearingtheCEmark.Theprocesswillleadtoadeterminationofwhetherapost-marketclinicalfollow-upstudyisrequiredandprovideguidanceforpost-marketclinicalmonitoringrequirementsifastudyisnotrequired.

2.Scope

TheworkinstructionappliestoallmedicaldevicebusinessesandsitesoperatingundertheTDIFoot/AnkleArray8chHealthcareQualityManagementSystem.

OnlymedicaldevicesbearingtheCEMarkwillberequiredtofollowthisworkinstruction.

3.References

ExternalReferences

Laws

▪CouncilDirective93/42/EECof14June1993concerningmedicaldevicesincludingamendmentsthrough05September2007

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）

4.RolesandResponsibilities

Important:

Whenatitleofapositionislistedinthisworkinstruction,itrelatestothatpositionoritsequivalent.

Belowaretherolesandresponsibilitiesdiscussedwithinthisdocument.

Table41:

RolesandResponsibilities

Role

Responsibility

DesignEngineeringand/orEngineeringRepresentative

∙ProvideconsultationtotheProductRegulatoryAffairsRepresentativeindeterminingforagivenproject/productwhetherapost-marketclinicalfollow-upstudyisrequired

∙ProvideconsultationtotheProductRegulatoryAffairsRepresentativetodetermineifanequivalentdeviceexists

∙ProvideconsultationtotheProductRegulatoryAffairsRepresentativeinidentifyingemergingrisksforthemedicaldevice

∙ProvideconsultationtotheResearchManagerordesigneetodeterminethetypeofpost-marketclinicalfollow-upstudytobeimplemented,ifapplicable

ProductRegulatoryAffairsRepresentative

∙Determineforagiveproject/productwhetherapost-marketclinicalfollow-upstudyisrequired

∙Determineifanequivalentdeviceexists

∙Identifypotentialemergingrisks

∙Reviewriskassessment

∙CompletethePost-MarketClinicalFollow-UpJustificationFormregardingdecisiontoperformastudy

∙CompletethePost-MarketClinicalFollow-UpPlanformthatdetailsthepost-marketclinicalfollow-upplan

∙Determinehowoftenclinicaldatamustbereviewed

∙ReviewandapprovetheclinicalevaluationperformedbytheResearchManagerordesignee

RegulatoryAffairsRepresentative

∙ProvideconsultationtotheResearchManagertodeterminethetypeofpost-marketclinicalfollow-upstudytobeimplemented,ifapplicable

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

5.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

GeneralRequirements

PriortoM3sign-off,theProductRegulatoryAffairsRepresentativeinconsultationwiththeResearchManagerordesigneeandtheDesignEngineeringand/orEngineeringRepresentativeshalldetermineforagivenproject/programwhetheraPMCFSisrequired.Theyshallalsodeterminethepost-marketclinicalfollow-upplan.

APMCFSmaynotberequiredforproductsforwhichmedium/long-termclinicalperformanceandsafetyisalreadyknownfromprevioususeofthedeviceorwhereotherappropriatepost-marketsurveillanceactivitieswouldprovidesufficientdatatoaddresstherisks.

DeterminingtheTypeofPost-MarketClinicalFollow-UpRequired

Post-marketclinicalmonitoringshallhaveoneoftwooutcomes,

（1）PMCFSrequiredor

（2）noPMCFSrequired.

TheneedforaPMCFSshallbebasedonacombinationofseveralfactorsdetailedinthissection.

TheProductRegulatoryAffairsRepresentativeinconsultationwiththeResearchManagerordesigneeandDesignEngineeringand/orEngineeringRepresentativeshalldeterminewhetheranequivalentdeviceexists.Equivalenceshallbedemonstratedinalltheessentialcharacteristicspreciselydefinedbelow.Equivalencemeans:

▪Clinical

▪Usedforthesameclinicalconditionorpurpose;

▪Usedatthesamesiteinthebody;

▪Usedinsimilarpopulation（includingage,anatomy,physiology）;

▪Havesimilarrelevantcriticalperformanceaccordingtoexpectedclinicaleffectforspecificintendeduse

▪Technical

▪Usedundersimilarconditionsofuse;

▪Havesimilarspecificationsandproperties;

▪Beofsimilardesign;

▪Usesimilardeploymentmethods

▪Havesimilarprinciplesofoperation

▪Biological

▪Sameorsimilaruseofmaterialsincontactwithhumantissuesorbodyfluids

Productsforwhichthemedium/longtermclinicalperformanceandsafetyisalreadyknownfromprevioususeofthedevice,orfromfullytransferableexperiencewithequivalentdevicesshallnotrequireaPMCFS.

NOTE:

Ifthedevicequotedasthe“equivalent”requiresaPMCFS,thenthenewproductshallbesubjecttothesamerequirement.

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;

Aproperlyconductedriskanalysisisessentialindeterminingwhatclinicalevidencemaybeneededforaparticulardevice.Anyrisksidentifiedasan“unacceptable”riskattheconclusionofthedevelopmentprocessshallrequireaPMCFS.Astudyshouldalsobeconsideredforrisksidentifiedas“acceptable”or“riskmitigationrequired”ifthedevicemeetsanyoftheothercharacteristicsidentifiedin5.2.1and5.2.2.TheriskassessmentshallbeperformedaccordingtotheRiskManagementProcedure.TheProductRegulatoryAffairsRepresentativeshallreviewtheriskassessment.

TheProductRegulatoryAffairsRepresentativeshallcompletethePostMarketClinicalFollow-UpStudyDeterminationForm（AppendixA）oncethedecisionregardingtheneedforastudyhasbeendetermined.

1NOTE:

ThisformmayalsobeusedasaguideinmakingthedeterminationabouttheneedtoperformaPMCFS.

TheProductRegulatoryAffairsRepresentativeshallcompletethePost-MarketClinicalFollow-UpPlan（AppendixB）thatdetailstheplanforpost-marketclinicalfollow-up.

TheResearchManagerordesigneeandMedicalAffairsRepresentativeshallreviewthePost-MarketClinicalFollow-UpJustificationFormandThePost-MarketClinicalFollow-UpPlantoconfirmthedecisionsregardingpost-marketclinicalmonitoring.