MEDDEV2.122上市后臨床跟蹤指南

DGENTERPRISEDirectorateGUnit4-PressureEquipment,MedicalDevices,MetrologyMEDICALMEDICALDEVICES:GuidancedocumentMEDDEV2.12-2May2023GUIDELINESONPOSTMARKETCLINICALFOLLOW-UP上市后臨床跟蹤指南上市后臨床跟蹤指南〔工業(yè)，其他有關(guān)各方在此期間，中間草案分發(fā)和評論的文件實行了密集的磋商進程。因此，這份文件反映了有關(guān)各方的代表在該領域?qū)嵭械尼t(yī)療設備的位置。ThepresentGuidelinesarepartofasetofGuidelinesrelatingtoquestionsofapplicationofEC-Directivesonmedicaldevices.Theyarelegallynotbinding.TheGuidelineshavebeencarefullydraftedthroughaprocessofintensiveconsultation of the various interested parties (competent authorities,Commission services, industries, other interested parties) during whichintermediatedraftswerecirculatedandcommentsweretakenupinthedocument.Therefore,thisdocumentreflectspositionstakenbyrepresentativesofinterestedpartiesin〔工業(yè)，其他有關(guān)各方在此期間，中間草案分發(fā)和評論的文件實行了密集的磋商進程。因此，這份文件反映了有關(guān)各方的代表在該領域?qū)嵭械尼t(yī)療設備的位置。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的根本原理和目標PMCF為了履行市場監(jiān)視義務后按3點通知機構(gòu)。131點附件或附件4〔AIMDD〕前的臨床調(diào)查。制造商可能在上市前階段收集不到罕見的并發(fā)癥或問題后，才廣泛使用，或/長的關(guān)鍵是查明和調(diào)查與對市場上使用的醫(yī)療器械相關(guān)的風險。ManufacturersshouldhavegeneralsystemsinplacetocoverPMSaswellashavingadefinedPMSstrategyforeachoftheirproducts/productrangesTherefore,PMCFappearsasamethodofchoiceforthispurpose.Itwill,forinstance,enablepatients”accesstonewtherapieswhileestablishingareviewprocessforlongtermsafetyfollow-upanddetectionofpossibleemergentrisksthatcannotbeadequatelydetectedbyrelyingsolelyonpre-marketclinicalinvestigations(giventherelativelyshortfollowuprequired)orproductexperience/vigilance.ImplementationPostmarketsurveillancemayincludeanumberofstrategiesinadditiontocomplainthandlingandvigilance:activesupervisionbycustomersurveys,inquiriesofusersandpatients,literaturereviews,PostmarketClinicalFollow-up,etc..Postmarketclinicalfollow-up(PMCF)throughclinicalstudiesandregistrieshasagreatimportanceamongthesestrategies.制造商應建立上市后監(jiān)視系統(tǒng)，除非每一個產(chǎn)品均建立了明確的制造商應建立上市后監(jiān)視系統(tǒng)，除非每一個產(chǎn)品均建立了明確的PMS〔上市后監(jiān)視〕的系統(tǒng)。因此，PMCF顯示為所選擇的這個目的的方法。它將，例如，使病人獲得，而建立一個長期的安全審查程序的療法的后續(xù)行動和可能的，不能充分依靠市場前的僅僅臨床調(diào)查中〔由于較短覺察突發(fā)風險檢測跟進要求〕或產(chǎn)品的閱歷覺察突發(fā)風險檢測跟進要求〕或產(chǎn)品的閱歷/警覺。實施上市后監(jiān)視除了處理投訴和警械系統(tǒng)還可以包括很多形式，例如：顧客反響治理用戶和患者調(diào)查，文獻評論，文獻評論，上市后的臨床隨訪等。通過臨床爭論和臨床登記處市場的后續(xù)行動〔PMCF〕這些戰(zhàn)略之間有一個格外重要的。PostMarketClinicalFollow-up(PMCF)shouldalwaysbeconsideredfordeviceswhereidentificationofpossibleemergingrisksandtheevaluationoflongtermsafetyandperformancearecritical.Inidentifyingsuchemergingrisk,thefollowingcriteriashouldbetakenintoaccount:innovation,whenthedesignofthedevice,thematerial,theprinciplesofoperation,thetechnology,orthemedicalindicationisnewseverityofthedisease,sensitivetargetpopulationriskyanatomicallocationwellknownriskfromtheliteraturewellknownriskofsimilarmarketeddevicesIdentificationofanacceptableriskduringpre-CEclinicalevaluation,whichshouldbemonitoredinalongertermand/orthroughalargerpopulation.Obviousdiscrepancybetweenthepremarketfollowuptimescalesandtheexpectedlifeoftheproduct上市后監(jiān)視〔上市后監(jiān)視〔PMCF〕可視為對設備可能消滅的風險和長期的安全和性能評價。在識別這種出現(xiàn)的風險，應考慮到下面的標準：嚴峻的疾病，敏感目標人群嚴峻的疾病，敏感目標人群危急的解剖位置文獻發(fā)表的風險已上市類似設備存在風險確認在一個確認在一個CE前臨床評價可承受的風險，應長期和/或監(jiān)測更多的臨床人員。臨床使用時間和產(chǎn)品的預期壽命的差異。AllPMCFshouldbeplanned.ThePMCFplancantaketheformofextendedfollow-upofpatientsenrolledinthepre-markettrials,and/oraprospectivestudyofarepresentativesubsetofpatientsafterthedeviceisplacedonthemarket.Itcanalsotaketheformofopenregistries.Thisplanwillneedtotakeintoaccount:ResultsoftheclinicalinvestigationincludingAdverseeventsidentifiedAveragelifeexpectancyofthedeviceTheclaimsmadebythemanufacturerforthedevicePerformancesforwhichequivalenceisclaimedNewinformationbecomingavailablePMCF,whencarriedout,mustalwaysbeperformedfortheuseoftheproductwithinitsintendedindicationsaccordingtoInstructionsforuse.Nationalregulationsonpostmarketclinicalstudiesmustbetakenintoaccount.全部全部PMCF應打算。該PMCF打算可以實行病人后續(xù)的觀看形式，包括市場前的評審，和/或設備已投放市場后有代表性病人的前瞻性爭論，可以實行開放登記表格，這個打算將需要考慮到：臨床調(diào)查，包括確定的不良大事結(jié)果設備的平均預期壽命設備的平均預期壽命設備制造商聲明聲明的性能適當可用的信息實施實施PMCF時，必需始終依據(jù)產(chǎn)品的預定適用范圍內(nèi)按使用說明使用。對上市后的臨床爭論必須考慮到相應國家的法規(guī)。TheinvolvedNotifiedBodyshouldreviewtheappropriatenessofthemanufacturer”sgeneralPMSprocedures,incorporatingPMCF,asrelevant,aswelltheirPMCFplan(s)andresultsforspecificproductsaspartofconformityassessmentproceduresandqualitymanagementsystemauditingThefollowupdurationshouldtakeintoaccounttheaveragelifeexpectancyoftheproductinitsindication.Therefore,incaseofadevicesubjecttoshorttermpremarketfollowupandintendedtostayinthepatientforitslifetime,alongerfollowupwillberequired.PMCFwillnotberequiredforproductsforwhichthelongtermclinicalperformanceandsafetyisalreadyknownfromprevioususeofthedevice.Inthecasetheassessmentofaproductisperformedthroughtheconceptofequivalence,PMCFshouldalwaysbeconsidered.PMCF打算〔s〕和特定產(chǎn)品的審計結(jié)果并打算留在患者一生中，一個較長的病人會跟進是必需。對需要長期臨床觀看和安全設備已經(jīng)的產(chǎn)品不需要PMCF。在狀況下可以通過等效的原則對個產(chǎn)品進展評估，原則對個產(chǎn)品進展評估，PMCF應始終考慮。PostMarketclinicalRequirements(Riskbasedmatrix)Thefollowingtablesetsouta‘triageapproach’andsuggestsgeneraladvicefortheevaluationofproductsunderdifferentcircumstances.Notifiedbodiesshouldbepartofthedecisionmakingwiththemanufacturerifapplicable.上市后的臨床需求〔基于風險模型〕下表列出了一個”分類方式”，并建議在不同狀況下對產(chǎn)品進展評價的一般意見。通告機構(gòu)應當是制造商作出推斷是否適用的一局部。PMCF Productspecificities Requiredactions產(chǎn)品特點noPMCF Products for which

the

需要實行的行動medium/long term performance and safety isalready known from previoususeofthedevice,orfromfullytransferable experience equivalentdevices(except**)

Allreceivedcomplaintsandadverseeventsdatashallbesystematicallyreviewed,andallproductrelatedadverseeventssuchasthosedescribedinAnnexII3.1oftheMDDmustbenotifiedtotherelevantCompetentAuthority(ies).Thisincludesallsourcesofinformationknownbythemanufacturer,includingpublishedliterature.Monitoringofpostmarketperformanceshouldtakeint該產(chǎn)品為中/長期的臨床表現(xiàn)和安全已經(jīng)從設備，從完全轉(zhuǎn)讓或具有同等設備〔除**以前使用已

accountrelevantdatapubliclyavailablewithsimilardevicesespeciallywhentheCEmarkingwasbasedonequivalence.知的閱歷〕PMCF Alwaysconsideredfordeviceswhereidentificationofpossibleemergingrisksandtheevaluationoflongtermsafetyandperformancearecritical(**)Productsquotedas“equivalent“deviceswherereferenceproductissubjectedtoPMCF和性能需要長期的評估的產(chǎn)品

全部收到的投訴及不良反響的數(shù)據(jù)，應系統(tǒng)地評價，以及全部與產(chǎn)品相關(guān)的，如附件二3.1MDD的描述的不良反響大事，必需預先通知有關(guān)主管部門〔們〕。這包括由制造商信息，包括出版文獻的全部來源。開與CE標志時。Sameasabove,Post-MarketClinicalFollow-up(PMCF)intheformoffollowupofallorajustifiablesubsetofpatientsalreadyenrolledinpre-marketingClinicalInv