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
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A/0
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3
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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-marketclinicalm