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(píng)論的文件實(shí)行了密集的磋商進(jìn)程。因此，這份文件反映了有關(guān)各方的代表在該領(lǐng)域?qū)嵭械尼t(yī)療設(shè)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(píng)論的文件實(shí)行了密集的磋商進(jìn)程。因此，這份文件反映了有關(guān)各方的代表在該領(lǐng)域?qū)嵭械尼t(yī)療設(shè)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(biāo)PMCF為了履行市場(chǎng)監(jiān)視義務(wù)后按3點(diǎn)通知機(jī)構(gòu)。131點(diǎn)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(jiàn)的并發(fā)癥或問(wèn)題后，才廣泛使用，或/長(zhǎng)的關(guān)鍵是查明和調(diào)查與對(duì)市場(chǎng)上使用的醫(yī)療器械相關(guān)的風(fēng)險(xiǎn)。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(yīng)建立上市后監(jiān)視系統(tǒng)，除非每一個(gè)產(chǎn)品均建立了明確的制造商應(yīng)建立上市后監(jiān)視系統(tǒng)，除非每一個(gè)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(gè)目的的方法。它將，例如，使病人獲得，而建立一個(gè)長(zhǎng)期的安全審查程序的療法的后續(xù)行動(dòng)和可能的，不能充分依靠市場(chǎng)前的僅僅臨床調(diào)查中〔由于較短覺(jué)察突發(fā)風(fēng)險(xiǎn)檢測(cè)跟進(jìn)要求〕或產(chǎn)品的閱歷覺(jué)察突發(fā)風(fēng)險(xiǎn)檢測(cè)跟進(jìn)要求〕或產(chǎn)品的閱歷/警覺(jué)。實(shí)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(xiàn)評(píng)論，文獻(xiàn)評(píng)論，上市后的臨床隨訪等。通過(guò)臨床爭(zhēng)論和臨床登記處市場(chǎng)的后續(xù)行動(dòng)〔PMCF〕這些戰(zhàn)略之間有一個(gè)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(duì)設(shè)備可能消滅的風(fēng)險(xiǎn)和長(zhǎng)期的安全和性能評(píng)價(jià)。在識(shí)別這種出現(xiàn)的風(fēng)險(xiǎn)，應(yīng)考慮到下面的標(biāo)準(zhǔn)：嚴(yán)峻的疾病，敏感目標(biāo)人群嚴(yán)峻的疾病，敏感目標(biāo)人群危急的解剖位置文獻(xiàn)發(fā)表的風(fēng)險(xiǎn)已上市類似設(shè)備存在風(fēng)險(xiǎn)確認(rèn)在一個(gè)確認(rèn)在一個(gè)CE前臨床評(píng)價(jià)可承受的風(fēng)險(xiǎn)，應(yīng)長(zhǎng)期和/或監(jiān)測(cè)更多的臨床人員。臨床使用時(shí)間和產(chǎn)品的預(yù)期壽命的差異。AllPMCFshouldbeplanned.ThePMCFplancantaketheformofextendedfollow-upofpatientsenrolledinthepre-markettrials,and/oraprospectivestudyofarepresentativesubsetofpatientsafterthedeviceisplacedonthemarket.Itcanalsotaketheformofopenregistries.Thisplanwillneedtotakeintoaccount:ResultsoftheclinicalinvestigationincludingAdverseeventsidentifiedAveragelifeexpectancyofthedeviceTheclaimsmadebythemanufacturerforthedevicePerformancesforwhichequivalenceisclaimedNewinformationbecomingavailablePMCF,whencarriedout,mustalwaysbeperformedfortheuseoftheproductwithinitsintendedindicationsaccordingtoInstructionsforuse.Nationalregulationsonpostmarketclinicalstudiesmustbetakenintoaccount.全部全部PMCF應(yīng)打算。該P(yáng)MCF打算可以實(shí)行病人后續(xù)的觀看形式，包括市場(chǎng)前的評(píng)審，和/或設(shè)備已投放市場(chǎng)后有代表性病人的前瞻性爭(zhēng)論，可以實(shí)行開(kāi)放登記表格，這個(gè)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(shè)備的平均預(yù)期壽命設(shè)備的平均預(yù)期壽命設(shè)備制造商聲明聲明的性能適當(dāng)可用的信息實(shí)施實(shí)施PMCF時(shí)，必需始終依據(jù)產(chǎn)品的預(yù)定適用范圍內(nèi)按使用說(shuō)明使用。對(duì)上市后的臨床爭(zhēng)論必須考慮到相應(yīng)國(guó)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(jì)結(jié)果并打算留在患者一生中，一個(gè)較長(zhǎng)的病人會(huì)跟進(jìn)是必需。對(duì)需要長(zhǎng)期臨床觀看和安全設(shè)備已經(jīng)的產(chǎn)品不需要PMCF。在狀況下可以通過(guò)等效的原則對(duì)個(gè)產(chǎn)品進(jìn)展評(píng)估，原則對(duì)個(gè)產(chǎn)品進(jìn)展評(píng)估，PMCF應(yīng)始終考慮。PostMarketclinicalRequirements(Riskbasedmatrix)Thefollowingtablesetsouta‘triageapproach’andsuggestsgeneraladvicefortheevaluationofproductsunderdifferentcircumstances.Notifiedbodiesshouldbepartofthedecisionmakingwiththemanufacturerifapplicable.上市后的臨床需求〔基于風(fēng)險(xiǎn)模型〕下表列出了一個(gè)”分類方式”，并建議在不同狀況下對(duì)產(chǎn)品進(jìn)展評(píng)價(jià)的一般意見(jiàn)。通告機(jī)構(gòu)應(yīng)當(dāng)是制造商作出推斷是否適用的一局部。PMCF Productspecificities Requiredactions產(chǎn)品特點(diǎn)noPMCF Products for which

the

需要實(shí)行的行動(dòng)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(zhǎng)期的臨床表現(xiàn)和安全已經(jīng)從設(shè)備，從完全轉(zhuǎn)讓或具有同等設(shè)備〔除**以前使用已

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

全部收到的投訴及不良反響的數(shù)據(jù)，應(yīng)系統(tǒng)地評(píng)價(jià)，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(yù)先通知有關(guān)主管部門(mén)〔們〕。這包括由制造商信息，包括出版文獻(xiàn)的全部來(lái)源。開(kāi)與CE標(biāo)志時(shí)。Sameasabove,Post-MarketClinicalFollow-up(PMCF)intheformoffollowupofallorajustifiablesubsetofpatientsalreadyenrolledinpre-marketingClinicalInv