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(exceptthereadingofr