上市后临床跟踪控制程序.docx
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上市后临床跟踪控制程序.docx
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上市后临床跟踪控制程序
上市后临床跟踪控制程序
(ISO13485-2016)
1.0PURPOSE
Thepurposeofthisworkinstructionistodefinetheprocesstodetermineanddocumentwhetherapost-marketclinicalfollow-upstudyisrequiredforTDIFoot/AnkleArray8chmedicaldevicesbearingtheCEmark.Theprocesswillleadtoadeterminationofwhetherapost-marketclinicalfollow-upstudyisrequiredandprovideguidanceforpost-marketclinicalmonitoringrequirementsifastudyisnotrequired.
2.0SCOPE
TheworkinstructionappliestoallmedicaldevicebusinessesandsitesoperatingundertheTDIFoot/AnkleArray8chHealthcareQualityManagementSystem.
OnlymedicaldevicesbearingtheCEMarkwillberequiredtofollowthisworkinstruction.
3.0REFERENCES
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-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
∙ProvideconsultationtotheProductRegulatoryAffairsRepresentativeindeterminingforagivenproject/productwhetherapost-marketclinicalfollow-upstudyisrequired
∙ProvideconsultationtotheProductRegulatoryAffairsRepresentativetodetermineifanequivalentdeviceexists
∙ProvideconsultationtotheProductRegulatoryAffairsRepresentativetoidentifypotentialemergingrisks
∙ReviewthePost-MarketClinicalFollow-UpJustificationformandPost-MarketClinicalFollow-UpPlanformtoconfirmthedecisionsregardingtheneedforapost-marketclinicalfollow-upstudyandclinicalfollow-up
∙Determinehowoftenclinicaldatamustbereviewed
∙Determinethetypeofpost-marketclinicalfollow-upstudytobeimplemented,ifapplicable
∙Reviewnewdata(i.e.literature,adverseevents,complaints,etc,)anddetermineifapost-marketclinicalfollow-upstudyisnecessarybasedonnewinformation(clinicalevaluation)
MedicalAffairsRepresentative
∙ReviewthePost-MarketClinicalFollow-UpJustificationformandPost-MarketClinicalFollow-UpPlanformtoconfirmthedecisionsregardingtheneedforapost-marketclinicalfollow-upstudyandclinicalfollow-up
∙ReviewandapprovetheclinicalevaluationperformedbytheResearchManagerordesignee
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.
NOTE:
ThisformmayalsobeusedasaguideinmakingthedeterminationabouttheneedtoperformaPMCFS.
5.2.6.TheProductRegulatoryAffairsRepresentativeshallcompletethePost-MarketClinicalFollow-UpPlan(AppendixB)thatdetailstheplanforpost-marketclinicalfollow-up.
5.2.7.TheResearchManagerordesigneeandMedicalAffairsRepresentativeshallreviewthePost-MarketClinicalFollow-UpJustificationFormandThePost-MarketClinicalFollow-UpPlantoconfirmthedecisionsrega
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