update on the international medical device regulators...
TRANSCRIPT
UpdateontheInternationalMedicalDevice
RegulatorsForum
MelissaTorres,ME,MSAssociateDirectorforInternationalAffairs
OfficeoftheCenterDirectorCenterforDevicesandRadiologicalHealth
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InternationalMedicalDeviceRegulatorsForum(IMDRF)
Accelerate International Regulatory
Convergence
• Forum established in 2011 to accelerate international medical device regulatory harmonization and convergence building on the work of the Global Harmonization Task Force (GHTF)
• Address common public health regulatory challenges to convergence due to the globalization of medical device production and the emergence of new technologies
• Accelerate innovation by clear and practical regulatory expectations
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IMDRFMissionandStrategicPlan
MissionTostrategicallyaccelerateinternationalmedicaldeviceregulatoryconvergencetopromoteanefficientandeffectiveregulatorymodelformedicaldevicesthatisresponsivetoemergingchallengesinthesectorwhileprotectingandmaximizingpublichealthandsafety.
StrategicPlan• EnhancePost-MarketSurveillance• ImprovetheEffectivenessandEfficiencyofPre-MarketReview
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IMDRFWorkingGroups
• ActiveWorkingGroups– Comprisedofregulatorsonlyorregulatorsandstakeholdersdependingonthetopic.– PatientRegistries– AdverseEventTerminology– GoodRegulatoryReviewPractices– UniqueDeviceIdentification(UDI)– RegulatedProductSubmission(RPS)– Standards– PatientSpecificDevices
• ClosedWorkingGroups– NationalCompetentAuthorityReport(NCAR)– SoftwareasaMedicalDevice(SaMD)– MedicalDeviceSingleAuditProgram(MDSAP)
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PatientRegistries
GoalTodevelopsharedessentialprinciplesofinformaticsinfrastructureandbestepidemiologicandstatisticalanalyticmethodologiestoenhancethequality,speedandcost-efficienciesofregulatoryscienceformedicaldevices.
Benefits• Linkingrelevantdatasourcesandtoolstoaninternationalsystemof
registrieswouldaddvaluetomultiplestakeholdersbyassuringanalysisvalidity
• Providesdefinitionsandqualifiersthatdefinetheimpact,value,andsustainabilityofregistries
• Buildsuponthesuccessesinbuildingnationalregistriesandinternationalcollaborations
• Notallcountriesmaybeabletocontributeregistrydatatoeverydeviceevaluation;however,allcountrieswillbenefit
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PatientRegistriesIMDRFDocuments
IMDRF/REGISTRYWG/N33FINAL:2016PrinciplesofInternationalSystemofRegistriesLinkedtoOtherDataSourcesandTools• Definesessentialprinciplesforlinkingelectronicpatient,deviceandoutcome
registriesand/orrelateddatarepositoriesoridentifierssuchasuniquedeviceidentifiers,includingtheprinciplesbehinddataaccess,security,informaticsformats,governanceandotherkeyareasrelatedtoglobalregulatoryapplicationsformedicaldeviceevaluation.
IMDRF/RegistryWG/N42FINAL:2017MethodologicalPrinciplesintheUseofInternationalMedicalDeviceRegistryData• Definesessentialprinciplesrelatedtooptimalmethodologiesfortheanalysis
ofheterogeneousdatasourcesappliedtomedicaldevicesafetysignaldetection,performance,andreliability.
CurrentWorkItem:• Developmentofaqualificationtoolforinternationalregistriestakinginto
considerationavarietyofregulatorydecisions.
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RelationshipofIMDRFRegistryDocuments
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CurrentWorkItem:ToolsforAssessingtheUsabilityofRegistriesin
SupportofRegulatoryDecision-Making
• Theregistryassessmenttoolmakesrecommendationswithregardtothesixregulatoryuses:– Primaryapproval– Expanded/Broadenedindication– Post-marketstudy– Post-marketsurveillance– ObjectivePerformanceCriteria/PerformanceGoals- OPCs/PGs– Devicetrackingandfieldsafetycorrectiveactions
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AssessmentChecklistforRegulatoryUseELEMENTS REGULATORYUSE
PrimaryApproval BroadeningIndication
PostMarketStudy
PostmarketSurveillance
DevelopmentofOPC/PG
DeviceTrackingandFieldSafetyCorrectiveActions
DeviceIdentificationUnambiguousDeviceIdentification(preferablyinternationallyrecognizedUDIsystem)
needed needed needed needed needed
PatientIdentification
PatientIdentification uniqueneeded
limitedacceptable
limitedacceptable
uniqueneeded
Linkability(Registrywithotherdatasource)Deterministic XX X XProbabilistic (not
recommended)XX XX XX
TransparencyandGovernance
Governancestructureandprocesses XX XX XX X XX XLegalrequirementsfordatacollection/handling
XX XX XX X XX X
PolicyonCOI XX XX XX XX XX XXPolicyonaccesstodata XX XX XX XX XX XXReport;Keyelementsandfrequencyofreports
X X X X X
Websiteandweb-reporting X X X X X X
Essentialinformationavailableforverificationbyrelevantauthority(e.g.competentauthority,notifiedbody)
XX XX XX XX
InformationonPatientDataProtection(e.g.ifExemptfromconsent,Opt-out,Opt-in)
XX XX XX XX XX
QualityandMethodologyProcessesLeadingtoActionableData
ListofRelevantVariablesandUseofControlledVocabularies
XX XX XX XX X X
Useofnationally/internationallyharmonizedminimumdatamodel
X X X X X
RegistryManagementprocesses(e.g.coverage,completeness,dataqualitycontrolandassurance,etc.)
XX XX XX XX XX
Conductofanalysesacrossdifferenttypesofanalysisframeworks
NA NA NA XX XX
LegendXX- HighlyRecommendedX- Desirable
- OptionalNA- NotApplicable
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Conclusion
HowcanyougetinvolvedinIMDRF?• Participateinworkinggroups• Reviewandprovidefeedbackondraftdocuments– “ToolsforAssessingtheUsabilityofRegistriesinSupportofRegulatoryDecisionMaking”• Publicconsultationfor2monthsclosingonDecember1• http://www.imdrf.org/consultations/cons-registries-n46-pd1-170817.asp
• AttendIMDRFstakeholdersessions– MeetingsinMarchandSeptember
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ThankYou