MEDDEV2.122上市后临床跟踪指南

DGENTERPRISEDirectorateGUnit4-PressureEquipment,MedicalDevices,MetrologyMEDICALMEDICALDEVICES:GuidancedocumentMEDDEV2.12-2May2023GUIDELINESONPOSTMARKETCLINICALFOLLOW-UP上市后临床跟踪指南上市后临床跟踪指南〔工业，其他有关各方在此期间，中间草案分发和评论的文件实行了密集的磋商进程。因此，这份文件反映了有关各方的代表在该领域实行的医疗设备的位置。ThepresentGuidelinesarepartofasetofGuidelinesrelatingtoquestionsofapplicationofEC-Directivesonmedicaldevices.Theyarelegallynotbinding.TheGuidelineshavebeencarefullydraftedthroughaprocessofintensiveconsultation of the various interested parties (competent authorities,Commission services, industries, other interested parties) during whichintermediatedraftswerecirculatedandcommentsweretakenupinthedocument.Therefore,thisdocumentreflectspositionstakenbyrepresentativesofinterestedpartiesin〔工业，其他有关各方在此期间，中间草案分发和评论的文件实行了密集的磋商进程。因此，这份文件反映了有关各方的代表在该领域实行的医疗设备的位置。Foreword:RationaleandGoalsofPMCFThisdocumentisintendedtobeaguideformanufacturersandnotifiedbodiesonhowtocarryoutPMCFinordertofulfillpostmarketsurveillanceobligationaccordingtopoint3.1ofannexII,point3.ofannexIV,point3ofannexV,point3.1ofannexVIorpoint4ofannexVIIofmedicaldevicedirective(addref.AIMDD)While clinical evidence is an essential element of the premarket conformityassessmentprocess,itisimportanttorecognizethelimitationsinherenttothesepremarketclinicalinvestigations.Theextentofthedatathatcanbegatheredinthepremarketphasedoesnotenablethemanufacturertodetectinfrequentcomplicationsorproblemsonlyapparentafterwidespreaduse,or/longtermperformanceissues.Aspartofthemanufacturer’squalitysystem,aprogramofappropriatepostmarketsurveillanceiskeytoidentifyingandinvestigatingrisksassociatedwiththeuseofmedicaldevicesplacedonthemarket.前言：前言：PMCF的根本原理和目标PMCF为了履行市场监视义务后按3点通知机构。131点附件或附件4〔AIMDD〕前的临床调查。制造商可能在上市前阶段收集不到罕见的并发症或问题后，才广泛使用，或/长的关键是查明和调查与对市场上使用的医疗器械相关的风险。ManufacturersshouldhavegeneralsystemsinplacetocoverPMSaswellashavingadefinedPMSstrategyforeachoftheirproducts/productrangesTherefore,PMCFappearsasamethodofchoiceforthispurpose.Itwill,forinstance,enablepatients”accesstonewtherapieswhileestablishingareviewprocessforlongtermsafetyfollow-upanddetectionofpossibleemergentrisksthatcannotbeadequatelydetectedbyrelyingsolelyonpre-marketclinicalinvestigations(giventherelativelyshortfollowuprequired)orproductexperience/vigilance.ImplementationPostmarketsurveillancemayincludeanumberofstrategiesinadditiontocomplainthandlingandvigilance:activesupervisionbycustomersurveys,inquiriesofusersandpatients,literaturereviews,PostmarketClinicalFollow-up,etc..Postmarketclinicalfollow-up(PMCF)throughclinicalstudiesandregistrieshasagreatimportanceamongthesestrategies.制造商应建立上市后监视系统，除非每一个产品均建立了明确的制造商应建立上市后监视系统，除非每一个产品均建立了明确的PMS〔上市后监视〕的系统。因此，PMCF显示为所选择的这个目的的方法。它将，例如，使病人获得，而建立一个长期的安全审查程序的疗法的后续行动和可能的，不能充分依靠市场前的仅仅临床调查中〔由于较短觉察突发风险检测跟进要求〕或产品的阅历觉察突发风险检测跟进要求〕或产品的阅历/警觉。实施上市后监视除了处理投诉和警械系统还可以包括很多形式，例如：顾客反响治理用户和患者调查，文献评论，文献评论，上市后的临床随访等。通过临床争论和临床登记处市场的后续行动〔PMCF〕这些战略之间有一个格外重要的。PostMarketClinicalFollow-up(PMCF)shouldalwaysbeconsideredfordeviceswhereidentificationofpossibleemergingrisksandtheevaluationoflongtermsafetyandperformancearecritical.Inidentifyingsuchemergingrisk,thefollowingcriteriashouldbetakenintoaccount:innovation,whenthedesignofthedevice,thematerial,theprinciplesofoperation,thetechnology,orthemedicalindicationisnewseverityofthedisease,sensitivetargetpopulationriskyanatomicallocationwellknownriskfromtheliteraturewellknownriskofsimilarmarketeddevicesIdentificationofanacceptableriskduringpre-CEclinicalevaluation,whichshouldbemonitoredinalongertermand/orthroughalargerpopulation.Obviousdiscrepancybetweenthepremarketfollowuptimescalesandtheexpectedlifeoftheproduct上市后监视〔上市后监视〔PMCF〕可视为对设备可能消灭的风险和长期的安全和性能评价。在识别这种出现的风险，应考虑到下面的标准：严峻的疾病，敏感目标人群严峻的疾病，敏感目标人群危急的解剖位置文献发表的风险已上市类似设备存在风险确认在一个确认在一个CE前临床评价可承受的风险，应长期和/或监测更多的临床人员。临床使用时间和产品的预期寿命的差异。AllPMCFshouldbeplanned.ThePMCFplancantaketheformofextendedfollow-upofpatientsenrolledinthepre-markettrials,and/oraprospectivestudyofarepresentativesubsetofpatientsafterthedeviceisplacedonthemarket.Itcanalsotaketheformofopenregistries.Thisplanwillneedtotakeintoaccount:ResultsoftheclinicalinvestigationincludingAdverseeventsidentifiedAveragelifeexpectancyofthedeviceTheclaimsmadebythemanufacturerforthedevicePerformancesforwhichequivalenceisclaimedNewinformationbecomingavailablePMCF,whencarriedout,mustalwaysbeperformedfortheuseoftheproductwithinitsintendedindicationsaccordingtoInstructionsforuse.Nationalregulationsonpostmarketclinicalstudiesmustbetakenintoaccount.全部全部PMCF应打算。该PMCF打算可以实行病人后续的观看形式，包括市场前的评审，和/或设备已投放市场后有代表性病人的前瞻性争论，可以实行开放登记表格，这个打算将需要考虑到：临床调查，包括确定的不良大事结果设备的平均预期寿命设备的平均预期寿命设备制造商声明声明的性能适当可用的信息实施实施PMCF时，必需始终依据产品的预定适用范围内按使用说明使用。对上市后的临床争论必须考虑到相应国家的法规。TheinvolvedNotifiedBodyshouldreviewtheappropriatenessofthemanufacturer”sgeneralPMSprocedures,incorporatingPMCF,asrelevant,aswelltheirPMCFplan(s)andresultsforspecificproductsaspartofconformityassessmentproceduresandqualitymanagementsystemauditingThefollowupdurationshouldtakeintoaccounttheaveragelifeexpectancyoftheproductinitsindication.Therefore,incaseofadevicesubjecttoshorttermpremarketfollowupandintendedtostayinthepatientforitslifetime,alongerfollowupwillberequired.PMCFwillnotberequiredforproductsforwhichthelongtermclinicalperformanceandsafetyisalreadyknownfromprevioususeofthedevice.Inthecasetheassessmentofaproductisperformedthroughtheconceptofequivalence,PMCFshouldalwaysbeconsidered.PMCF打算〔s〕和特定产品的审计结果并打算留在患者一生中，一个较长的病人会跟进是必需。对需要长期临床观看和安全设备已经的产品不需要PMCF。在状况下可以通过等效的原则对个产品进展评估，原则对个产品进展评估，PMCF应始终考虑。PostMarketclinicalRequirements(Riskbasedmatrix)Thefollowingtablesetsouta‘triageapproach’andsuggestsgeneraladvicefortheevaluationofproductsunderdifferentcircumstances.Notifiedbodiesshouldbepartofthedecisionmakingwiththemanufacturerifapplicable.上市后的临床需求〔基于风险模型〕下表列出了一个”分类方式”，并建议在不同状况下对产品进展评价的一般意见。通告机构应当是制造商作出推断是否适用的一局部。PMCF Productspecificities Requiredactions产品特点noPMCF Products for which

the

需要实行的行动medium/long term performance and safety isalready known from previoususeofthedevice,orfromfullytransferable experience equivalentdevices(except**)

Allreceivedcomplaintsandadverseeventsdatashallbesystematicallyreviewed,andallproductrelatedadverseeventssuchasthosedescribedinAnnexII3.1oftheMDDmustbenotifiedtotherelevantCompetentAuthority(ies).Thisincludesallsourcesofinformationknownbythemanufacturer,includingpublishedliterature.Monitoringofpostmarketperformanceshouldtakeint该产品为中/长期的临床表现和安全已经从设备，从完全转让或具有同等设备〔除**以前使用已

accountrelevantdatapubliclyavailablewithsimilardevicesespeciallywhentheCEmarkingwasbasedonequivalence.知的阅历〕PMCF Alwaysconsideredfordeviceswhereidentificationofpossibleemergingrisksandtheevaluationoflongtermsafetyandperformancearecritical(**)Productsquotedas“equivalent“deviceswherereferenceproductissubjectedtoPMCF和性能需要长期的评估的产品

全部收到的投诉及不良反响的数据，应系统地评价，以及全部与产品相关的，如附件二3.1MDD的描述的不良反响大事，必需预先通知有关主管部门〔们〕。这包括由制造商信息，包括出版文献的全部来源。开与CE标志时。Sameasabove,Post-MarketClinicalFollow-up(PMCF)intheformoffollowupofallorajustifiablesubsetofpatientsalreadyenrolledinpre-marketingClinicalInv