上市后临床跟踪管理程序.docx

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

上市后临床跟踪控制程序

文件编号：

QP-29

版本：

A/0

生效日期：

页码：

3

编制：

审核：

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-GeneralMEDDEVGuidelinesonPostMarketClinicalFollow-UpdatedMay2004

MEDDEVguidelinesonmedicaldevice-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.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,.,wherethedesignofthedevice,thematerials,theprinciplesofoperation,thetechnologyorthemedicalindicationsarenovel;

highriskanatomicallocations.,heart,centralnervoussystem,etc.）;

severityofdisease/treatmentchallenges;

sensitivityoftargetpopulation.,infants,children,pregnantwomen,etc.）;

identificationofanacceptableriskduringthepre-CEclinicalevaluation,whichshouldbemonitoredinalongertermand/orthroughalargerpopulation;

wellknownrisksidentifiedfromtheliteratureorsimilarmarketeddevices;

discrepancybetweenthepre-marketfollow-uptimescalesandtheexpectedlifeoftheproduct;

Aproperlyconductedriskanalysisisessentialindeterminingwhatclinicalevidencemaybeneededforaparticulardevice.Anyrisksidentifiedasan“unacceptable”riskattheconclusionofthedevelopmentprocessshallrequireaPMCFS.Astudyshouldalsobeconsideredforrisksidentifiedas“acceptable”or“riskmitigationrequired”ifthedevicemeetsanyoftheothercharacteristicsidentifiedin5.2.1andTheriskassessmentshallbeperformedaccordingtotheRiskManagementProcedure.TheProductRegulatoryAffairsRepresentativeshallreviewtheriskassessment.

TheProductRegulatoryAffairsRepresentativeshallcompletethePostMarketClinicalFollow-UpStudyDeterminationForm（AppendixA）oncethedecisionregardingtheneedforastudyhasbeendetermined.

1NOTE:

ThisformmayalsobeusedasaguideinmakingthedeterminationabouttheneedtoperformaPMCFS.

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

TheResearchManagerordesigneeandMedicalAffairsRepresentativeshallreviewthePost-MarketClinicalFollow-UpJustificationFormandThePost-MarketClinicalFollow-UpPlantoconfirmthedecisionsregardingpost-marketclinical