IVDR Class D类通用规范CS（英文）.docx

COMMISSIONIMPLEMENTINGREGULATION(EU)2022/1107of4July2022layingdowncommonspecificationsforcertainclassDinvitrodiagnosticmedicaldevicesinaccordancewithRegulation(EU)2017/746oftheEuropeanParliamentandoftheCouncil(TextwithEEArelevance)THEEUROPEANCOMMISSION,HavingregardtotheTreatyontheFunctioningoftheEuropeanUnion,HavingregardtoRegulation(EU)2017/746oftheEuropeanParliamentandoftheCouncilof5April2017oninvitrodiagnosticmedicaldevicesandrepealingDirective98/79/ECandCommissionDecision2010/227/EU(,),andinparticularArticle9(1)thereof,Whereas:(I)ForcertainclassDinvitrodiagnosticmedicaldevicesfallingwithinthescopeofRegulation(EU)2017/746,harmonisedstandardsdonotexistasregardscertainrequirementsofAnnexItothatRegulation,andthereisaneedtoaddresspublichealthconcernsastheriskassociatedwiththeuseofthosedevicesissignificantforpublichealthandpatientsafety.Itisthereforeappropriatetoadoptcommonspecificationsforthosedevicesinrespectofthoserequirements.RegUlatiC)n(EU)2017/746replacesDirective98/79/ECoftheEuropeanParliamentandoftheCouncil0).ThecommontechnicalspecificationssetoutinCommissionDecision2002/364/EC(三)forcertaindevicescoveredbyDirective98/79/ECremainrelevant.Thosecommontechnicalspecificationshavethereforebeentakenintoaccountandwherenecessaryupdatedtoreflectthestateoftheart.(3)Toallowmanufacturers,othereconomicoperators,notifiedbodiesandotheractorstoadapttothisRegulation,andtoensureitsproperapplication,itisappropriatetodeferitsapplication.However,intheinterestofpublichealthandpatientsafety,manufacturersshouldbeallowedtocomplywiththecommonspecificationslaiddowninthisRegulationonavoluntarybasisbeforeitsdateofapplication.(4)Toensureacontinuoushighlevelofsafetyandperformanceofdevices,asatransitionalmeasureitshouldbeprovidedthatdevicesthatareinconformitywithDecision2002/364/ECaretobepresumedtobeinconformitywiththerequirementsforcertainperformancecharacteristicssetoutinAnnexItoRegulation(EU)2017/746untilthedateofapplicationofthisRegulation.(5)TheMedicalDeviceCoordinationGrouphasbeenconsulted.(6)ThemeasuresprovidedforinthisRegulationareinaccordancewiththeopinionoftheCommitteeonMedicalDevices,HASADOPTEDTHISREGULATION:Article 1CommonspecificationsThisRegulationlaysdowncommonspecificationsforcertainclassDinvitrodiagnosticmedicaldevicesinrespectoftherequirementsregardingtheperformancecharacteristicssetoutinSection9.1,points(a)and(b),Section9.3andSection9.4,point(a),ofAnnexItoRegulation(EU)2017/746.AnnexIlaysdowncommonspecificationsfordevicescoveredbyAnnexesIItoXIII,asspecifiedinthatAnnex.AnnexIIlaysdowncommonspecificationsfordevicesintendedfordetectionofbloodgroupantigensintheABO,Rh,Kell,DuffyandKiddbloodgroupsystems.AnnexIIIlaysdowncommonspecificationsfordevicesintendedfordetectionorquantificationofmarkersofhumanimmunodeficiencyvirus(HIV)infection.AnnexIVlaysdowncommonspecificationsfordevicesintendedfordetectionorquantificationofmarkersofhumanT-cellIymphotropicvirus(HTLV)infection.AnnexVlaysdowncommonspecificationsfordevicesintendedfordetectionorquantificationofmarkersofhepatitisCvirus(HCV)infection.AnnexVIlaysdowncommonspecificationsfordevicesintendedfordetectionorquantificationofmarkersofhepatitisBvirus(HBV)infection.AnnexVIIlaysdowncommonspecificationsfordevicesintendedfordetectionorquantificationofmarkersofhepatitisDvirus(HDV)infection.AnnexVIIIlaysdowncommonspecificationsfordevicesintendedfordetectionofmarkersofvariantCreutzfeldt-Jakobdisease(vCJD).AnnexIXlaysdowncommonspecificationsfordevicesintendedfordetectionorquantificationofmarkersofcytomegalovirus(CMV)infection.AnnexXlaysdowncommonspecificationsfordevicesintendedfordetectionorquantificationofmarkersofEpstein-Barrvirusinfection(EBV).AnnexXIlaysdowncommonspecificationsfordevicesintendedfordetectionofmarkersofTreponemapalliduminfection.AnnexXIIlaysdowncommonspecificationsfordevicesintendedfordetectionorquantificationofmarkersofTrypanosomacruziinfection.AnnexXIIIlaysdowncommonspecificationsfordevicesintendedfordetectionorquantificationofmarkersofsevereacuterespiratorysyndromecoronavirus2(SARS-CoV-2)infection.Article 2DefinitionsForthepurposesofthisRegulation,thefollowingdefinitionsapply:(l)/truepositive'meansaspecimenknowntobepositiveforthetargetmarkerandcorrectlyclassifiedbythedevice;(2)7alsenegative'meansaspecimenknowntobepositiveforthetargetmarkerandmisclassifiedbythedevice;(3)7alsepositive'meansaspecimenknowntobenegativeforthetargetmarkerandmisclassifiedbythedevice;(4)/thelimitofdetection'(zLOD,)meansthesmallestamountofthetargetmarkerthatcanbedetected;(5)/nucleicacidamplificationtechniques'(zNAT,)meansmethodsofdetectionand/orquantificationofnucleicacidsbyeitheramplificationofatargetsequence,byamplificationofasignalorbyhybridisation;(6)zNATsystem,meansthecombinationofdevicesusedforextraction,amplificationanddetectionofnucleicacids;(7)7apidtest,meansaqualitativeorsemi-quantitativeinvitrodiagnosticmedicaldevice,usedsinglyorinasmallseries,whichinvolvesnon-automatedprocedures(exceptthereadingofresults)andhasbeendesignedtogiveafastresult;'robustness'meansthecapacityofananalyticalproceduretoremainunaffectedbysmallbutdeliberatevariationsinmethodparametersandprovidesanindicationofitsreliabilityduringnormalusage;(9/CrOSS-reactivity'meanstheabilityofnon-targetanalytesormarkerstocausefalsepositiveresultsinanassaybecauseofsimilarity,e.g.theabilityofnon-specificantibodiesbindingtoatestantigenofanantibodyassay,ortheabilityofnon-targetnucleicaddstobereactiveinaNATassay;(10)/interference,meanstheabilityofunrelatedsubstancestoaffecttheresultsinanassay;(Il)zWhoIesystemfailurerate,meansthefrequencyoffailureswhentheentireprocessisperformedasprescribedbythemanufacturer;(12)7irst-lineassay/meansadeviceusedtodetectamarkeroranalyte,andtheuseofwhichmaybefollowedbytheuseofaconfirmatoryassay;devicesintendedsolelytobeusedtomonitorapreviouslydeterminedmarkeroranalytearenotconsideredfirst-lineassays;(13)/confirmatoryassay,meansadeviceusedfortheconfirmationofareactiveresultfromafirstlineassay;(14)zsupplementalassay,meansadevicethatisusedtoprovidefurtherinformationfortheinterpretationofthetestresultofanotherassay;(15)/virustypingdevice'meansadeviceusedfortypingwithalreadyknownpositivesamples,notusedforprimarydiagnosisofinfectionorforscreening;(16)/95%positivecut-offvalue,meanstheanalyteconcentrationwhere95%oftestrunsgivepositiveresultsfollowingserialdilutionsofaninternationalreferencematerial,whereavailable,e.g.aWorldHealthOrganisation(WHO)InternationalStandardorreferencematerialcalibratedagainsttheWHOInternationalStandard.Article 3Transitionalprovisions1. From25July2022until25July2024,devicesthatareinconformitywiththecommontechnicalspecificationssetoutinDecision2002/364/ECshallbepresumedtobeinconformitywiththerequirementsregardingtheperformancecharacteristicssetoutinSection9.1,points(a)and(b),Section9.3andSection9.4,point(a),ofAnnexItoRegulation(EU)2017/746.DuringthatperiodmanufacturersofdevicesthatarenotinconformitywiththecommontechnicalspecificationssetoutinDecision2002/364/ECshalldulyjustifythattheyhaveadoptedsolutionsthatensurealevelofsafetyandperformancethatisatleastequivalentthereto.2. From25July2022until25July2024devicesthatareinconformitywiththecommonspecificationssetoutinthisRegulationshallbepresumedtobeinconformitywiththerequirementsregardingtheperformancecharacteristicssetoutinSection9.1,points(a)and(b),Section9.3andSection9.4,point(a),ofAnnexItoRegulation(EU)2017/746.Article 4EntryintoforceanddateofapplicationThisRegulationshallenterintoforceonthetwentiethdayfollowingthatofitspublicationintheOfficialJournaloftheEuropeanUnion.Itshallapplyfrom25July2024.However,Article3shallapplyfrom25July2022.ThisRegulationshallbebindinginitsentiretyanddirectlyapplicableinallMemberStates.DoneatBrussels,4July2022.FortheCommissionThePresidentUrsulaVONDERLEYEN(,)OJL117,5.5.2017,p.176.(2) Directive98/79/ECoftheEuropeanParliamentandoftheCouncilof27October1998oninvitrodiagnosticmedicaldevices(OJL331,7.12.1998,p.1).(?)CommissionDecision2002/364/ECof7May2002oncommontechnicalspecificationsforinvitro-diagnosticmedicaldevices(OJL131.16.5.2002,p.17).ANNEXIGENERALCOMMONSPECIFICATIONSPartI-RequirementsforperformancecharacteristicsofdevicescoveredbyAnnexesIItoXIIIPerformancecharacteristicsRequirementAllperformancecharacteristicssetoutinSection9.1,points(a)and(b),Section9.3andSection9.4,point(a),ofAnnexItoRegulation(EU)2017/746l.Thedeterminationofperformancecharacteristicsshallbecarriedoutindirectcomparisonwithastate-of-the-artdevice.ThedeviceusedforcomparisonshallbeonebearingCEmarking,ifonthemarketatthetimeoftheperformanceevaluation.2.Devicesusedfordeterminationofstatusofspecimensusedindeterminationofperformancecharacteristicsshallbestate-of-the-artdevicesbearingCEmarking.3.Ifdiscrepantresultsareidentifiedaspartofdeterminationofperformancecharacteristics,theseresultsshallberesolvedasfaraspossible,byoneormoreofthefollowing:byevaluationofthediscrepantspecimeninfurtherdevices,byuseofanalternativemethodormarker,byareviewoftheclinicalstatusanddiagnosisofthepatient,bythetestingoffollow-upspecimens.4.ThedeterminationofperformancecharacteristicsshallbeperformedonapopulationequivalenttotheEuropeanpopulation.Wholesystemfailurerate5.Aspartoftherequiredriskanalysisthewholesystemfailurerateleadingtofalsenegativeresultsshallbedeterminedinrepeatassaysonlow-positivespecimens.Analyticalsensitivityandanalyticalspecificity,interference6.Fordevicesintendedforusewithplasmathemanufacturershallverifytheperformanceofthedeviceusingallanticoagulantswhichthemanufacturerindicatesforusewiththedevice,foratleast50plasmaspecimens(fordevicesintendedfordetectionand/orquantificationofinfectiousagents,25positiveand25negative).Analyticalanddiagnosticspecificity,interferenceandcross-reactivity7.Themanufacturershallselectthepotentialinterferingsubstancestobeevaluatedtakingaccountofthecompositionofthereagentsandconfigurationofthedevice.Batch-to-batchconsistency8 .Fordevicesintendedtodetectantigensandantibodies,themanufacturersbatchtestingcriteriashallensurethateverybatchconsistentlyidentifiestherelevantantigens,epitopes,andantibodiesandissuitablefortheclaimedspecimentypes.9 .Themanufacturer'sbatchreleasetestingforfirst-lineassaysshallincludeatleast100specimensnegativefortherelevantanalyte(；).PartII-RequirementsforperformancecharacteristicsofdevicesreferredtoinAnnexesIIItoXIIIPerformancecharacteristicRequirementAnalyticalanddiagnosticsensitivity10 .Devicesintendedbythemanufacturerfortestingbodyfluidsotherthanserumorplasma,e.g.urine,saliva,etc.,shallmeetthesamerequirementsasserumorplasmadevices.Themanufacturershalltestspecimensfromthesameindividualsinboththedevicestobeapprovedandinarespectiveserumorplasmadevice.9)11 .Devicesforself-testingshallmeetthesamerequirementsasrespectivedevicesforprofessionaluse.12 .Positivespecimensusedintheperformanceevaluationshallbeselectedtoreflectdifferentstagesoftherespectivedisease(s)zdifferentantibodypatterns,differentgenotypes,differentsubtypes,mutants,etc.13 .Seroconversionpanelsshallstartwithanegativebleed(s)andshallhavenarrowbleedingintervalsasfaraspossible.Wherethisisnotpossible,manufacturersshallprovideajustificationintheperformanceevaluationreport.14 .Fordevicesintendedbythemanufacturertobeusedwithserumandplasmatheperformanceevaluationmustdemonstrateserumtoplasmaequivalency.Thisshallbedemonstratedforatleast25positivedonations.15 .Fordevicesdetectingorquantifyingantigensornucleicacids,thetargetantigen(s)ortargetnucleicacidregion(s)respectivelyshallbespecifiedintheinstructionsforuse.16 .Fordevicesdetectingorquantifyingantibodiesagainstaninfectiousagent,thetargetantigen(s)ofthoseantibodiesshallbespecifiedintheinstructionsforuse.Analyticalanddiagnosticspecificity17.Devicesintendedbythemanufacturerfortestingbodyfluidsotherthanserumorplasma,e.g.urine,salivazetc.,shallmeetthesamerequirementsasserumorplasmadevices.Theperformanceevaluationshalltestspecimensfromthesameindividualsinboththedevicestobeapprovedandinarespectiveserumorplasmadevice.(?)18.Devicesforself-testingshallmeetthesamerequirementsasrespectivedevicesforprofessionaluse.19.Negativespecimensusedinaperformanceevaluationshallbedefinedsoastoreflectthetargetpopulationforwhichthedeviceisintended,suchasblooddonors,hospitalisedpatients,pregnantwomen,etc.20.Specificityshallbebasedonrepeatedlyreactivefalsepositiveresultsinspecimensnegativeforthetargetmarker.21.Fordevicesintendedbythemanufacturertobeusedwithserumandplasmatheperformanceevaluationmustdemonstrateserumtoplasmaequivalency.Thisshallbedemonstratedforatleast25negativedonations.Analyticalanddiagnosticspecificity,interferenceandcross-reactivity22.Themanufacturershallincludespecimenssuchas,whereapplicable:specimensrepresentingrelatedinfections,specimensfrommultigravidazi.e.womenwhohavehadmorethanonepregnancy,orrheumatoidfactor(RF)positivepatients,specimenscontaininghumanantibodiestocomponentsoftheexpressionsystem,forexampleanti-Ecoli,oranti-yeast.Performancesobtainedbylaypersons23.Relevantpartsoftheperformanceevaluationshallbecarriedout(orrepeated)byappropriatelaypersonstovalidatetheoperationofthedeviceandtheinstructionsforuse.Thelaypersonsselectedfortheperformanceevaluationshallberepresentativeoftheintendedusersgroups.(l)ThisrequirementshallnotapplytodevicescoveredbyTablesIand2ofAnnexXlII.(2)ThisrequirementshallnotapplytodevicesreferredtoinTables4,5and6ofAnnexXIII.ANNEXIICOMMONSPECIFICATIONSFORDEVICESINTENDEDFORDETECTIONOFBLOODGROUPANTIGENSINTHEABO,RH,KELL,DUFFYANDKIDDBLOODGROUPSYSTEMSScopeThisAnnexappliestodevicesintendedfordetectionofbloodgroupantigensintheABO,Rh,Kell,DuffyandKiddbloodgroupsystems.Table 1 appliestoperformanceevaluationofdevicesdetectingbloodgroupantigensintheABO,Rh,Kell,DuffyandKiddbloodgroupsystems.Table 2 appliestomanufacturerbatch-to-batchconsistencytestingofreagentsandreagentproductstodeterminebloodgroupantigensintheABO,Rh,Kell,DuffyandKiddbloodgroupsystems(testreagents,controlmaterials).Table1.PerformanceevaluationofdevicesdetectingbloodgroupantigensintheABO,Rh,Kell,DuffyandKiddbloodgroupsystemsReagentspecificityNumberoftestspermethodclaimedbythemanufacturerTotalnumberofspecimenstobetestedforalaunchdeviceTotalnumberofSpecimenstobetestedforanewformulation,oruseofwell-characterisedreagentsGeneralqualificationcriteriaSpecificqualificationcriteriaAcceptancecriteriaAnti-ABOl(Anti-A),Anti-AB02(Anti-B)zAnti-AB03(Anti-A,B)250030001000Clinicalspecimens:10%ofthetestpopulationNeonatalspecimens:>2%ofthetestpopulationABOspecimensshallinclude>40%AandBantigenpositivespecimenswhichmayincludespecimensfromgroupA,groupBandgroupABAllofthereagentsshallshowcomparableperformancetostate-of-the-artCEmarkeddeviceswithregardtoclaimedreactivityofthedevice.ForCEmarkeddeviceswheretheapplicationorusehasbeenchangedorextended,furthertestingshallbecarriedoutinaccordancewiththerequirementsoutlinedincolumn2above("NumberOfteStSp