上市后临床跟踪控制程序Word文件下载.docx

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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）

4.0ROLESANDRESPONSIBILITIES

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

∙ProvideconsultationtotheProductRegulatoryAffairsRepresentativetoidentifypotentialemergingrisks

∙ReviewthePost-MarketClinicalFollow-UpJustificationformandPost-MarketClinicalFollow-UpPlanformtoconfirmthedecisionsregardingtheneedforapost-marketclinicalfollow-upstudyandclinicalfollow-up

∙Determinethetypeofpost-marketclinicalfollow-upstudytobeimplemented,ifapplicable

∙Reviewnewdata（i.e.literature,adverseevents,complaints,etc,）anddetermineifapost-marketclinicalfollow-upstudyisnecessarybasedonnewinformation（clinicalevaluation）

MedicalAffairsRepresentative

5.0WORKINSTRUCTION

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

5.1.GeneralRequirements

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

5.1.2.APMCFSmaynotberequiredforproductsforwhichmedium/long-termclinicalperformanceandsafetyisalreadyknownfromprevioususeofthedeviceorwhereotherappropriatepost-marketsurveillanceactivitieswouldprovidesufficientdatatoaddresstherisks.

5.2.DeterminingtheTypeofPost-MarketClinicalFollow-UpRequired

Post-marketclinicalmonitoringshallhaveoneoftwooutcomes,

（1）PMCFSrequiredor

（2）noPMCFSrequired.

TheneedforaPMCFSshallbebasedonacombinationofseveralfactorsdetailedinthissection.

5.2.1.TheProductRegulatoryAffairsRepresentativeinconsultationwiththeResearchManagerordesigneeandDesignEngineeringand/orEngineeringRepresentativeshalldeterminewhetheranequivalentdeviceexists.Equivalenceshallbedemonstratedinalltheessentialcharacteristicspreciselydefinedbelow.Equivalencemeans:

Clinical

Usedforthesameclinicalconditionorpurpose;

Usedatthesamesiteinthebody;

Usedinsimilarpopulation（includingage,anatomy,physiology）;

Havesimilarrelevantcriticalperformanceaccordingtoexpectedclinicaleffectforspecificintendeduse

Technical

Usedundersimilarconditionsofuse;

Havesimilarspecificationsandproperties;

Beofsimilardesign;

Usesimilardeploymentmethods

Havesimilarprinciplesofoperation

Biological

Sameorsimilaruseofmaterialsincontactwithhumantissuesorbodyfluids

5.2.2.Productsforwhichthemedium/longtermclinicalperformanceandsafetyisalreadyknownfromprevioususeofthedevice,orfromfullytransferableexperiencewithequivalentdevicesshallnotrequireaPMCFS.

NOTE:

Ifthedevicequotedasthe“equivalent”requiresaPMCFS,thenthenewproductshallbesubjecttothesamerequirement.

5.2.3.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;

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

5.2.5.TheProductRegulatoryAffairsRepresentativeshallcompletethePostMarketClinicalFollow-UpStudyDeterminationForm（AppendixA）oncethedecisionregardingtheneedforastudyhasbeendetermined.

ThisformmayalsobeusedasaguideinmakingthedeterminationabouttheneedtoperformaPMCFS.

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

5.2.7.TheResearchManagerordesigneeandMedicalAffairsRepresentativeshallreviewthePost-MarketClinicalFollow-UpJustificationFormandThePost-MarketClinicalFollow-UpPlantoconfirmthedecisionsrega