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

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上市后临床追踪控制程序

文件编号：

QP-29

版本：

A/0

见效日期：

页码：

19

编制：

审察：

赞同：

1.

PURPOSE

Thepurposeofthis

workinstruction

is

todefine

theprocessto

determine

anddocumentwhetherapost-marketclinicalfollow-upstudyisrequired

forTDIFoot/AnkleArray8chmedicaldevicesbearingtheCEmark.The

processwillleadtoadeterminationofwhetherapost-marketclinical

follow-upstudyis

requiredandprovide

guidance

forpost-market

clinical

monitoringrequirementsifastudyisnotrequired.

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-a

guideformanufacturersandnotifiedbodiesdatedApril2009

GHTFPost-MarketClinicalFollow-UpStudies;SG5（PD）N4R7（Proposeddocument23July2008）

GHTFClinicalInvestigations;SG5（PD）N3R7（20January2008）

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ProductRegulatoryAffairsRepresentative

RegulatoryAffairsRepresentative

DesignEngineeringand/orEngineeringRepresentative

Role

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4.ROLESANDRESPONSIBILITIES

Important:

Whenatitleofapositionislistedinthisworkinstruction,itrelatestothatpositionoritsequivalent.

Belowaretherolesandresponsibilitiesdiscussedwithinthisdocument.

Table4-1:

RolesandResponsibilities

Responsibility

ProvideconsultationtotheProductRegulatoryAffairsRepresentativeindeterminingforagivenproject/productwhetherapost-marketclinicalfollow-upstudyisrequired

ProvideconsultationtotheProductRegulatoryAffairs

Representativetodetermineifanequivalentdeviceexists

ProvideconsultationtotheProductRegulatoryAffairs

Representativeinidentifyingemergingrisksforthemedical

device

ProvideconsultationtotheResearchManagerordesigneeto

determinethetypeofpost-marketclinicalfollow-upstudyto

beimplemented,ifapplicable

Determineforagiveproject/productwhetherapost-marketclinicalfollow-upstudyisrequired

Determineifanequivalentdeviceexists

Identifypotentialemergingrisks

Reviewriskassessment

CompletethePost-MarketClinicalFollow-UpJustificationFormregardingdecisiontoperformastudy

CompletethePost-MarketClinicalFollow-UpPlanformthat

detailsthepost-marketclinicalfollow-upplan

Determinehowoftenclinicaldatamustbereviewed

Reviewandapprovetheclinicalevaluationperformedbythe

ResearchManagerordesignee

ProvideconsultationtotheResearchManagertodeterminethe

typeofpost-marketclinicalfollow-upstudytobeimplemented,ifapplicable

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Table4-1:

RolesandResponsibilities

Role

Responsibility

ResearchManageror

ProvideconsultationtotheProductRegulatoryAffairs

designee

Representativeindeterminingforagivenproject/product

whetherapost-marketclinicalfollow-upstudyisrequired

ProvideconsultationtotheProductRegulatoryAffairs

Representativetodetermineifanequivalentdeviceexists

ProvideconsultationtotheProductRegulatoryAffairs

Representativetoidentifypotentialemergingrisks

ReviewthePost-Market

Clinical

Follow-Up

Justification

form

and

Post-MarketClinicalFollow-UpPlanformtoconfirmthe

decisionsregardingtheneedforapost-marketclinical

follow-upstudyandclinicalfollow-up

Determinehowoftenclinicaldatamustbereviewed

Determinethetypeofpost-marketclinicalfollow-upstudyto

beimplemented,ifapplicable

Reviewnewdata（i.e.literature,adverseevents,complaints,

etc,）anddetermineifapost-marketclinicalfollow-upstudy

isnecessarybasedonnewinformation（clinicalevaluation）

MedicalAffairs

ReviewthePost-Market

Clinical

Follow-Up

Justification

form

and

Representative

Post-MarketClinicalFollow-UpPlanformtoconfirmthe

decisionsregardingtheneedforapost-marketclinical

follow-upstudyandclinicalfollow-up

Reviewandapprovetheclinicalevaluationperformedbythe

ResearchManagerordesignee

5.WORKINSTRUCTION

Post-marketclinicalmonitoringisanessentialelementinestablishinglongtermsafetyfollow-updataandpossibleemergentrisksformedical

devices.Theserisksanddatacannotadequatelybedetectedandcharacterizedbyrelyingsolelyonpre-marketclinicalinvestigations.

Postmarketclinicalmonitoringmayincludeacombinationofseveralstrategies:

Productcomplaintreview

Post-marketeventreportingreviewofusersandpatients

Literaturereview

Post-marketclinicalfollow-upstudies（PMCFS）

ThisworkinstructionwascreatedtodeterminewhenaPMCFSisnecessarytomaintainanadequatepost-marketsurveillancesystem,asrequiredby

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theMedicalDeviceDirective93/42/ECC（MDD）asamendedbyMDD2007/47/EC.

Itwillalsoprovideguidanceonthepost-marketclinicalmonitoring

requirementsifaPMCFSisnotrequired.

Figure5-1:

High-LevelProcessOverviewforPost-MarketClinicalFollow-Up

Determinewhetheranequivalent

deviceexists

Identifyresidualrisks/emerging

risks

PMCFS

Determination

ReviewRiskAssessment

document

EvaluateneedforPMCFS

PMCFS

Required?

YES

NO

PerformPMCFSinaccordance

withGEHC_GQP_10.03and

Ataminimum,reviewclinicaldata

including,AE抯,complaintsand

literature

Reviewnewdataanddetermine

theneedtoaPMCFSbasedon

newinformation

5.1.GeneralRequirements

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

5.1.2.APMCFSmaynotberequiredforproductsforwhichmedium/long-termclinicalperformanceandsafetyisalreadyknownfromprevioususeofthedeviceorwhereotherappropriatepost-marketsurveillanceactivitieswouldprovidesufficientdatatoaddresstherisks.

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5.2.DeterminingtheTypeofPost-MarketClinicalFollow-Up

Required

Post-marketclinicalmonitoringshallhaveoneoftwooutcomes,

（1）PMCFSrequiredor

（2）noPMCFSrequired.

TheneedforaPMCFSshallbebasedonacombinationofseveralfactorsdetailedinthissection.

5.2.1.TheProductRegulatoryAffairsRepresentativeinconsultationwiththeResearchManagerordesigneeandDesignEngineeringand/orEngineeringRepresentativeshalldeterminewhetheranequivalentdeviceexists.Equivalenceshallbedemonstratedinalltheessentialcharacteristicspreciselydefinedbelow.Equivalencemeans:

Clinical

Usedforthesameclinicalconditionorpurpose;

Usedatthesamesiteinthebody;

Usedinsimilarpopulation（includingage,anatomy,

physiology）;

Havesimilarrelevantcriticalperformanceaccordingto

expectedclinicaleffectforspecificintendeduse

Technical

Usedundersimilarconditionsofuse;

Havesimilarspecificationsandproperties;

Beofsimilardesign;

Usesimilardeploymentmethods

Havesimilarprinciplesofoperation

Biological

Sameorsimilaruseofmaterialsincontactwithhumantissuesorbodyfluids

5.2.2.Productsforwhichthemedium/longtermclinicalperformanceandsafety

isalreadyknownfromprevioususeofthedevice,orfromfullytransferableexperiencewithequivalentdevicesshallnotrequirea

PMCFS.

NOTE:

Ifthedevicequotedasthe“equivalent”requiresaPMCFS,then

thenewproductshallbesubjecttothesamerequirement.

5.2.3.TheneedforaPMCFSshallbedeterminedbasedontheidentificationofresidualrisksthatmayimpacttherisk/benefitratio.Astudyshould

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alwaysbeconsideredfordeviceswheretheidentificationofpossibleemergingrisksandtheevaluationoflongtermsafetyandperformanceareessential.TheProductRegulatoryAffairsRepresentativein

consultationwiththeResearchManagerordesigneeandDesignEngineeringand/orEngineeringRepresentativeshallidentifysuchemergingrisk,thefollowingcriteriashouldbetakenintoaccount:

innovation,e.g.,wherethedesignofthedevice,thematerials,theprinciplesofoperation,thetechnologyorthemedicalindicationsarenovel;

highriskanatomicallocations（i.e.,heart,centralnervous

system,etc.）;

severityofdisease/treatmentchallenges;

sensitivityoftargetpopulation（i.e.,infants,children,

pregnantwomen,etc.）;

identificationofanacceptableriskduringthepre-CEclinicalevaluation,whichshouldbemonitoredinalongertermand/orthroughalargerpopulation;

wellknownrisksidentifiedfromtheliteratureorsimilar

marketeddevices;

discrepancybetweenthepre-marketfollow-uptimescalesandtheexpectedlifeoftheproduct;

5.2.4.Aproperlyconductedriskanalysisisessentialindeterminingwhatclinicalevidencemaybeneededforaparticulardevice.Anyrisks

identifiedasan“unacceptable”riskattheconclusionofthedevelopmentprocessshallrequireaPMCFS.Astudyshouldalsobe

consideredforrisksidentifiedas“acceptable”or“riskmitigationrequired”ifthedevicemeetsanyoftheothercharacteristics

ide