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1、COMMISSIONIMPLEMENTINGREGULATION(EU)2022/1107of4July2022layingdowncommonspecificationsforcertainclassDinvitrodiagnosticmedicaldevicesinaccordancewithRegulation(EU)2017/746oftheEuropeanParliamentandoftheCouncil(TextwithEEArelevance)THEEUROPEANCOMMISSION,HavingregardtotheTreatyontheFunctioningoftheEur
2、opeanUnion,HavingregardtoRegulation(EU)2017/746oftheEuropeanParliamentandoftheCouncilof5April2017oninvitrodiagnosticmedicaldevicesandrepealingDirective98/79/ECandCommissionDecision2010/227/EU(,),andinparticularArticle9(1)thereof,Whereas:(I)ForcertainclassDinvitrodiagnosticmedicaldevicesfallingwithin
3、thescopeofRegulation(EU)2017/746,harmonisedstandardsdonotexistasregardscertainrequirementsofAnnexItothatRegulation,andthereisaneedtoaddresspublichealthconcernsastheriskassociatedwiththeuseofthosedevicesissignificantforpublichealthandpatientsafety.Itisthereforeappropriatetoadoptcommonspecificationsfo
4、rthosedevicesinrespectofthoserequirements.RegUlatiC)n(EU)2017/746replacesDirective98/79/ECoftheEuropeanParliamentandoftheCouncil0).ThecommontechnicalspecificationssetoutinCommissionDecision2002/364/EC(三)forcertaindevicescoveredbyDirective98/79/ECremainrelevant.Thosecommontechnicalspecificationshavet
5、hereforebeentakenintoaccountandwherenecessaryupdatedtoreflectthestateoftheart.(3)Toallowmanufacturers,othereconomicoperators,notifiedbodiesandotheractorstoadapttothisRegulation,andtoensureitsproperapplication,itisappropriatetodeferitsapplication.However,intheinterestofpublichealthandpatientsafety,ma
6、nufacturersshouldbeallowedtocomplywiththecommonspecificationslaiddowninthisRegulationonavoluntarybasisbeforeitsdateofapplication.(4)Toensureacontinuoushighlevelofsafetyandperformanceofdevices,asatransitionalmeasureitshouldbeprovidedthatdevicesthatareinconformitywithDecision2002/364/ECaretobepresumed
7、tobeinconformitywiththerequirementsforcertainperformancecharacteristicssetoutinAnnexItoRegulation(EU)2017/746untilthedateofapplicationofthisRegulation.(5)TheMedicalDeviceCoordinationGrouphasbeenconsulted.(6)ThemeasuresprovidedforinthisRegulationareinaccordancewiththeopinionoftheCommitteeonMedicalDev
8、ices,HASADOPTEDTHISREGULATION:Article 1CommonspecificationsThisRegulationlaysdowncommonspecificationsforcertainclassDinvitrodiagnosticmedicaldevicesinrespectoftherequirementsregardingtheperformancecharacteristicssetoutinSection9.1,points(a)and(b),Section9.3andSection9.4,point(a),ofAnnexItoRegulation
9、(EU)2017/746.AnnexIlaysdowncommonspecificationsfordevicescoveredbyAnnexesIItoXIII,asspecifiedinthatAnnex.AnnexIIlaysdowncommonspecificationsfordevicesintendedfordetectionofbloodgroupantigensintheABO,Rh,Kell,DuffyandKiddbloodgroupsystems.AnnexIIIlaysdowncommonspecificationsfordevicesintendedfordetect
10、ionorquantificationofmarkersofhumanimmunodeficiencyvirus(HIV)infection.AnnexIVlaysdowncommonspecificationsfordevicesintendedfordetectionorquantificationofmarkersofhumanT-cellIymphotropicvirus(HTLV)infection.AnnexVlaysdowncommonspecificationsfordevicesintendedfordetectionorquantificationofmarkersofhe
11、patitisCvirus(HCV)infection.AnnexVIlaysdowncommonspecificationsfordevicesintendedfordetectionorquantificationofmarkersofhepatitisBvirus(HBV)infection.AnnexVIIlaysdowncommonspecificationsfordevicesintendedfordetectionorquantificationofmarkersofhepatitisDvirus(HDV)infection.AnnexVIIIlaysdowncommonspec
12、ificationsfordevicesintendedfordetectionofmarkersofvariantCreutzfeldt-Jakobdisease(vCJD).AnnexIXlaysdowncommonspecificationsfordevicesintendedfordetectionorquantificationofmarkersofcytomegalovirus(CMV)infection.AnnexXlaysdowncommonspecificationsfordevicesintendedfordetectionorquantificationofmarkers
13、ofEpstein-Barrvirusinfection(EBV).AnnexXIlaysdowncommonspecificationsfordevicesintendedfordetectionofmarkersofTreponemapalliduminfection.AnnexXIIlaysdowncommonspecificationsfordevicesintendedfordetectionorquantificationofmarkersofTrypanosomacruziinfection.AnnexXIIIlaysdowncommonspecificationsfordevi
14、cesintendedfordetectionorquantificationofmarkersofsevereacuterespiratorysyndromecoronavirus2(SARS-CoV-2)infection.Article 2DefinitionsForthepurposesofthisRegulation,thefollowingdefinitionsapply:(l)/truepositivemeansaspecimenknowntobepositiveforthetargetmarkerandcorrectlyclassifiedbythedevice;(2)7als
15、enegativemeansaspecimenknowntobepositiveforthetargetmarkerandmisclassifiedbythedevice;(3)7alsepositivemeansaspecimenknowntobenegativeforthetargetmarkerandmisclassifiedbythedevice;(4)/thelimitofdetection(zLOD,)meansthesmallestamountofthetargetmarkerthatcanbedetected;(5)/nucleicacidamplificationtechni
16、ques(zNAT,)meansmethodsofdetectionand/orquantificationofnucleicacidsbyeitheramplificationofatargetsequence,byamplificationofasignalorbyhybridisation;(6)zNATsystem,meansthecombinationofdevicesusedforextraction,amplificationanddetectionofnucleicacids;(7)7apidtest,meansaqualitativeorsemi-quantitativein
17、vitrodiagnosticmedicaldevice,usedsinglyorinasmallseries,whichinvolvesnon-automatedprocedures(exceptthereadingofresults)andhasbeendesignedtogiveafastresult;robustnessmeansthecapacityofananalyticalproceduretoremainunaffectedbysmallbutdeliberatevariationsinmethodparametersandprovidesanindicationofitsre
18、liabilityduringnormalusage;(9/CrOSS-reactivitymeanstheabilityofnon-targetanalytesormarkerstocausefalsepositiveresultsinanassaybecauseofsimilarity,e.g.theabilityofnon-specificantibodiesbindingtoatestantigenofanantibodyassay,ortheabilityofnon-targetnucleicaddstobereactiveinaNATassay;(10)/interference,
19、meanstheabilityofunrelatedsubstancestoaffecttheresultsinanassay;(Il)zWhoIesystemfailurerate,meansthefrequencyoffailureswhentheentireprocessisperformedasprescribedbythemanufacturer;(12)7irst-lineassay/meansadeviceusedtodetectamarkeroranalyte,andtheuseofwhichmaybefollowedbytheuseofaconfirmatoryassay;d
20、evicesintendedsolelytobeusedtomonitorapreviouslydeterminedmarkeroranalytearenotconsideredfirst-lineassays;(13)/confirmatoryassay,meansadeviceusedfortheconfirmationofareactiveresultfromafirstlineassay;(14)zsupplementalassay,meansadevicethatisusedtoprovidefurtherinformationfortheinterpretationofthetes
21、tresultofanotherassay;(15)/virustypingdevicemeansadeviceusedfortypingwithalreadyknownpositivesamples,notusedforprimarydiagnosisofinfectionorforscreening;(16)/95%positivecut-offvalue,meanstheanalyteconcentrationwhere95%oftestrunsgivepositiveresultsfollowingserialdilutionsofaninternationalreferencemat
22、erial,whereavailable,e.g.aWorldHealthOrganisation(WHO)InternationalStandardorreferencematerialcalibratedagainsttheWHOInternationalStandard.Article 3Transitionalprovisions1. From25July2022until25July2024,devicesthatareinconformitywiththecommontechnicalspecificationssetoutinDecision2002/364/ECshallbep
23、resumedtobeinconformitywiththerequirementsregardingtheperformancecharacteristicssetoutinSection9.1,points(a)and(b),Section9.3andSection9.4,point(a),ofAnnexItoRegulation(EU)2017/746.DuringthatperiodmanufacturersofdevicesthatarenotinconformitywiththecommontechnicalspecificationssetoutinDecision2002/36
24、4/ECshalldulyjustifythattheyhaveadoptedsolutionsthatensurealevelofsafetyandperformancethatisatleastequivalentthereto.2. From25July2022until25July2024devicesthatareinconformitywiththecommonspecificationssetoutinthisRegulationshallbepresumedtobeinconformitywiththerequirementsregardingtheperformancecha
25、racteristicssetoutinSection9.1,points(a)and(b),Section9.3andSection9.4,point(a),ofAnnexItoRegulation(EU)2017/746.Article 4EntryintoforceanddateofapplicationThisRegulationshallenterintoforceonthetwentiethdayfollowingthatofitspublicationintheOfficialJournaloftheEuropeanUnion.Itshallapplyfrom25July2024
26、.However,Article3shallapplyfrom25July2022.ThisRegulationshallbebindinginitsentiretyanddirectlyapplicableinallMemberStates.DoneatBrussels,4July2022.FortheCommissionThePresidentUrsulaVONDERLEYEN(,)OJL117,5.5.2017,p.176.(2) Directive98/79/ECoftheEuropeanParliamentandoftheCouncilof27October1998oninvitro
27、diagnosticmedicaldevices(OJL331,7.12.1998,p.1).(?)CommissionDecision2002/364/ECof7May2002oncommontechnicalspecificationsforinvitro-diagnosticmedicaldevices(OJL131.16.5.2002,p.17).ANNEXIGENERALCOMMONSPECIFICATIONSPartI-RequirementsforperformancecharacteristicsofdevicescoveredbyAnnexesIItoXIIIPerforma
28、ncecharacteristicsRequirementAllperformancecharacteristicssetoutinSection9.1,points(a)and(b),Section9.3andSection9.4,point(a),ofAnnexItoRegulation(EU)2017/746l.Thedeterminationofperformancecharacteristicsshallbecarriedoutindirectcomparisonwithastate-of-the-artdevice.Thedeviceusedforcomparisonshallbe
29、onebearingCEmarking,ifonthemarketatthetimeoftheperformanceevaluation.2.Devicesusedfordeterminationofstatusofspecimensusedindeterminationofperformancecharacteristicsshallbestate-of-the-artdevicesbearingCEmarking.3.Ifdiscrepantresultsareidentifiedaspartofdeterminationofperformancecharacteristics,these
30、resultsshallberesolvedasfaraspossible,byoneormoreofthefollowing:byevaluationofthediscrepantspecimeninfurtherdevices,byuseofanalternativemethodormarker,byareviewoftheclinicalstatusanddiagnosisofthepatient,bythetestingoffollow-upspecimens.4.Thedeterminationofperformancecharacteristicsshallbeperformedo
31、napopulationequivalenttotheEuropeanpopulation.Wholesystemfailurerate5.Aspartoftherequiredriskanalysisthewholesystemfailurerateleadingtofalsenegativeresultsshallbedeterminedinrepeatassaysonlow-positivespecimens.Analyticalsensitivityandanalyticalspecificity,interference6.Fordevicesintendedforusewithpl
32、asmathemanufacturershallverifytheperformanceofthedeviceusingallanticoagulantswhichthemanufacturerindicatesforusewiththedevice,foratleast50plasmaspecimens(fordevicesintendedfordetectionand/orquantificationofinfectiousagents,25positiveand25negative).Analyticalanddiagnosticspecificity,interferenceandcr
33、oss-reactivity7.Themanufacturershallselectthepotentialinterferingsubstancestobeevaluatedtakingaccountofthecompositionofthereagentsandconfigurationofthedevice.Batch-to-batchconsistency8 .Fordevicesintendedtodetectantigensandantibodies,themanufacturersbatchtestingcriteriashallensurethateverybatchconsi
34、stentlyidentifiestherelevantantigens,epitopes,andantibodiesandissuitablefortheclaimedspecimentypes.9 .Themanufacturersbatchreleasetestingforfirst-lineassaysshallincludeatleast100specimensnegativefortherelevantanalyte(；).PartII-RequirementsforperformancecharacteristicsofdevicesreferredtoinAnnexesIIIt
35、oXIIIPerformancecharacteristicRequirementAnalyticalanddiagnosticsensitivity10 .Devicesintendedbythemanufacturerfortestingbodyfluidsotherthanserumorplasma,e.g.urine,saliva,etc.,shallmeetthesamerequirementsasserumorplasmadevices.Themanufacturershalltestspecimensfromthesameindividualsinboththedevicesto
36、beapprovedandinarespectiveserumorplasmadevice.9)11 .Devicesforself-testingshallmeetthesamerequirementsasrespectivedevicesforprofessionaluse.12 .Positivespecimensusedintheperformanceevaluationshallbeselectedtoreflectdifferentstagesoftherespectivedisease(s)zdifferentantibodypatterns,differentgenotypes
37、,differentsubtypes,mutants,etc.13 .Seroconversionpanelsshallstartwithanegativebleed(s)andshallhavenarrowbleedingintervalsasfaraspossible.Wherethisisnotpossible,manufacturersshallprovideajustificationintheperformanceevaluationreport.14 .Fordevicesintendedbythemanufacturertobeusedwithserumandplasmathe
38、performanceevaluationmustdemonstrateserumtoplasmaequivalency.Thisshallbedemonstratedforatleast25positivedonations.15 .Fordevicesdetectingorquantifyingantigensornucleicacids,thetargetantigen(s)ortargetnucleicacidregion(s)respectivelyshallbespecifiedintheinstructionsforuse.16 .Fordevicesdetectingorqua
39、ntifyingantibodiesagainstaninfectiousagent,thetargetantigen(s)ofthoseantibodiesshallbespecifiedintheinstructionsforuse.Analyticalanddiagnosticspecificity17.Devicesintendedbythemanufacturerfortestingbodyfluidsotherthanserumorplasma,e.g.urine,salivazetc.,shallmeetthesamerequirementsasserumorplasmadevi
40、ces.Theperformanceevaluationshalltestspecimensfromthesameindividualsinboththedevicestobeapprovedandinarespectiveserumorplasmadevice.(?)18.Devicesforself-testingshallmeetthesamerequirementsasrespectivedevicesforprofessionaluse.19.Negativespecimensusedinaperformanceevaluationshallbedefinedsoastoreflec
41、tthetargetpopulationforwhichthedeviceisintended,suchasblooddonors,hospitalisedpatients,pregnantwomen,etc.20.Specificityshallbebasedonrepeatedlyreactivefalsepositiveresultsinspecimensnegativeforthetargetmarker.21.Fordevicesintendedbythemanufacturertobeusedwithserumandplasmatheperformanceevaluationmus
42、tdemonstrateserumtoplasmaequivalency.Thisshallbedemonstratedforatleast25negativedonations.Analyticalanddiagnosticspecificity,interferenceandcross-reactivity22.Themanufacturershallincludespecimenssuchas,whereapplicable:specimensrepresentingrelatedinfections,specimensfrommultigravidazi.e.womenwhohaveh
43、admorethanonepregnancy,orrheumatoidfactor(RF)positivepatients,specimenscontaininghumanantibodiestocomponentsoftheexpressionsystem,forexampleanti-Ecoli,oranti-yeast.Performancesobtainedbylaypersons23.Relevantpartsoftheperformanceevaluationshallbecarriedout(orrepeated)byappropriatelaypersonstovalidate
44、theoperationofthedeviceandtheinstructionsforuse.Thelaypersonsselectedfortheperformanceevaluationshallberepresentativeoftheintendedusersgroups.(l)ThisrequirementshallnotapplytodevicescoveredbyTablesIand2ofAnnexXlII.(2)ThisrequirementshallnotapplytodevicesreferredtoinTables4,5and6ofAnnexXIII.ANNEXIICO
45、MMONSPECIFICATIONSFORDEVICESINTENDEDFORDETECTIONOFBLOODGROUPANTIGENSINTHEABO,RH,KELL,DUFFYANDKIDDBLOODGROUPSYSTEMSScopeThisAnnexappliestodevicesintendedfordetectionofbloodgroupantigensintheABO,Rh,Kell,DuffyandKiddbloodgroupsystems.Table 1 appliestoperformanceevaluationofdevicesdetectingbloodgroupant
46、igensintheABO,Rh,Kell,DuffyandKiddbloodgroupsystems.Table 2 appliestomanufacturerbatch-to-batchconsistencytestingofreagentsandreagentproductstodeterminebloodgroupantigensintheABO,Rh,Kell,DuffyandKiddbloodgroupsystems(testreagents,controlmaterials).Table1.Performanceevaluationofdevicesdetectingbloodg
47、roupantigensintheABO,Rh,Kell,DuffyandKiddbloodgroupsystemsReagentspecificityNumberoftestspermethodclaimedbythemanufacturerTotalnumberofspecimenstobetestedforalaunchdeviceTotalnumberofSpecimenstobetestedforanewformulation,oruseofwell-characterisedreagentsGeneralqualificationcriteriaSpecificqualificat
48、ioncriteriaAcceptancecriteriaAnti-ABOl(Anti-A),Anti-AB02(Anti-B)zAnti-AB03(Anti-A,B)250030001000Clinicalspecimens:10%ofthetestpopulationNeonatalspecimens:2%ofthetestpopulationABOspecimensshallinclude40%AandBantigenpositivespecimenswhichmayincludespecimensfromgroupA,groupBandgroupABAllofthereagentsshallshowcomparableperformancetostate-of-the-artCEmarkeddeviceswithregardtoclaimedreactivityofthedevice.ForCEmarkeddeviceswheretheapplicationorusehasbeenchangedorextended,furthertestingshallbecarriedoutinaccordancewiththerequirementsoutlinedincolumn2above(NumberOfteStSp
