MEDDEV 2.7-4 临床调查-制造商和公告机构的指南

MEDDEV2.7-4临床调查-制造商和公告机构的指南Ref.Ares(2021)2067487-18/05/2021EUROPEANCOMMISSIONDIRECTORATEGENERALforHEALTHandCONSUMERSConsumerAffairsCosmeticsandMedicalDevicesMEDDEV2.7/4December2021GUIDELINESONMEDICALDEVICESGUIDELINESONCLINICALINVESTIGATION:AGUIDEFORMANUFACTURERSANDNOTIFIEDBODIESNoteThepresentGuidelinesarepartofasetofGuidelinesrelatingtoquestionsofapplicationofEC-DirectivesonmedicalDevices.Theyarelegallynotbinding.TheGuidelineshavebeencarefullydraftedthroughaprocessofintensiveconsultationofthevariousinterestparties(competentauthorities,Commissionservices,industries,otherinterestedparties)duringwhichintermediatedraftswherecirculatedandcommentsweretakenupinthedocument.Therefore,thisdocumentreflectspositionstakenbyrepresentativesofinterestpartiesinthemedicaldevicessector.CONTENTS1Introduction(3)2Scope(3)3References(4)4Definitions(5)5GeneralPrinciplesWhenConsideringtheNeedforaClinicalInvestigation(6)6GeneralPrinciplesofClinicalInvestigationDesign(7)7EthicalConsiderationsforClinicalInvestigations(10)1IntroductionTheseguidelinesarebasedontheguidancedocumentSG5/N3:2021oftheGlobalHarmonizationTaskForce.Theyareadaptedtotherequirementsonclinicalinvestigationslaidoutinannex7ofdirective90/385/EECandinannexXofdirective93/42/EECasamendedbydirective2021/47/EC.Theclinicalinvestigationsshallbeperformedasdescribedintheseannexes.Theyreflecttheconsensusviewofthevariousinterestedpartieswithregardtoclinicalinvestigationsundertheabove-mentionedmedicaldevicesdirectives.Whatisaclinicalinvestigation?Aclinicalinvestigationisdefinedas“anysystematicinvestigationorstudyinorononeormorehumansubjects,undertakentoassessthesafetyand/orperformanceofamedicaldevice.”(SG5/N1:2021).Theundertakingofaclinicalinvestigationisascientificprocessthatrepresentsonemethodofgeneratingclinicaldata.Whatistheobjectiveofaclinicalinvestigation?Theobjectiveofaclinicalinvestigationistoassessthesafetyandclinicalperformanceofthedeviceinquestionandevaluatewhetherthedeviceissuitableforthepurpose(s)andthepopulation(s)forwhichitisintended(ENISO14155-1:2021).Howisaclinicalinvestigationconducted?ENISO14155-1:2021ClinicalInvestigationofMedicalDevicesforHumanSubjects-GeneralRequirementsdetailsthegeneralrequirementsfortheconductofclinicalinvestigationsandENISO14155-2:2021ClinicalInvestigationofMedicalDevicesforHumanSubjects-ClinicalInvestigationPlancontainsdetailedinformationabouttheprocedureandcontentsofaclinicalinvestigationplan.Clinicalinvestigationsmusttakeintoaccountscientificprinciplesunderlyingthecollectionofclinicaldataalongwithacceptedethicalstandardssurroundingtheuseofhumansubjects.Theclinicalinvestigationobjectivesanddesignshouldbedocumentedinaclinicalinvestigationplan.2ScopeTheprimarypurposeofthisdocumentistoprovideguidanceinrelationto:?whenaclinicalinvestigationshouldbeundertakenforamedicaldevicetodemonstratecompliancewiththerelevantEssentialRequirements;and?thegeneralprinciplesofclinicalinvestigationsinvolvingmedicaldevices.Giventhewidediversityofmedicaldevicesandtheirassociatedrisks,thisdocumentisnotintendedtoprovidecomprehensiveguidanceforclinicalinvestigationsofspecificmedicaldevices.Theguidancecontainedwithinthisdocumentisintendedtoapplytomedicaldevicesgenerallyandtocombinationproductsregulatedasmedicaldevices.Itisnotintendedtocoverinvitrodiagnosticmedicaldevices.Additionally,thisdocumentwasdraftedprimarilytoaddresstheuseofClinicalInvestigationstosupportclinicalevaluationandaconformityassessmentprocedure.Someaspectsofthisdocumentmayapplytostudiesconductedfollowingcommercialreleaseofadevice.Aseparateguidancedocumentspecificallyaddressespost-marketclinicalfollow-up(MEDDEV2.12/2:ClinicalEvaluation-PostMarketClinicalFollow-up).3ReferencesDirective90/385/EEC,asamendedbyDirective2021/47/ECDirective93/42/EEC,asamendedbyDirective2021/47/ECInterpretativeDocumentsMEDDEV2.7.1Rev.3;December2021ClinicalEvaluation:AGuideforManufacturersandNotifiedBodiesMEDDEV2.7.1,Appendix1;December2021EvaluationofClinicalData–AGuideforManufacturersandNotifiedBodies–Appendix1:ClinicalEvaluationofCoronaryStentsMEDDEV2.7.2;December2021GuideforCompetentAuthoritiesinMakinganAssessmentofClinicalInvestigationsNotificationMEDDEV2.12/2;May2021ClinicalEvaluation-PostMarketClinicalFollow-upGHTFfinaldocumentsSG5/N1:2021ClinicalEvidence–KeydefinitionsandConceptsSG5/N2:2021ClinicalEvaluationHarmonized/InternationalstandardsENISO14155-1:2021Clinicalinvestigationofmedicaldevicesforhumansubjects–Part1GeneralrequirementsENISO14155-2:2021Clinicalinvestigationofmedicaldevicesforhumansubjects–Part2ClinicalinvestigationplansENISO14971:2021ApplicationofriskmanagementtomedicaldevicesOtherReferencesWorldMedicalAssociation–DeclarationofHelsinki-Ethicalprinciplesformedicalresearchinvolvinghumansubjects4DefinitionsClinicalData:Thesafetyand/orperformanceinformationthatisgeneratedfromtheuseofadevice.Clinicaldataaresourcedfrom:—clinicalinvestigation(s)ofthedeviceconcerned;or—clinicalinvestigation(s)orotherstudiesreportedinthescientificliterature,ofasimilardeviceforwhichequivalencetothedeviceinquestioncanbedemonstrated