上市后临床跟踪管理程序Word文档下载推荐.docx
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上市后临床跟踪管理程序Word文档下载推荐.docx
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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-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
∙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.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.
No
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