IVDR Class D类通用规范CS（英文）.docx

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1、COMMISSIONIMP1EMENTINGREGU1ATION(EU)2023/1107of4Ju1y20231ayingdowncommonspecificationsforcertainc1assDinvitrodiagnosticmedica1devicesinaccordancewithRegu1ation(EU)2017/746oftheEuropeanPar1iamentandoftheCounci1(TextwithEEAre1evance)THEEUROPEANCOMMISSION,HavingregardtotheTreatyontheFunctioningoftheEur

2、opeanUnion,HavingregardtoRegu1ation(EU)2017/746oftheEuropeanPar1iamentandoftheCounci1of5Apri12017oninvitrodiagnosticmedica1devicesandrepea1ingDirective98/79/ECandCommissionDecision2010/227/EU(,),andinparticu1arArtic1e9(1)thereof,Whereas:(I)Forcertainc1assDinvitrodiagnosticmedica1devicesfa11ingwithin

3、thescopeofRegu1ation(EU)2017/746,harmonisedstandardsdonotexistasregardscertainrequirementsofAnnexItothatRegu1ation,andthereisaneedtoaddresspub1ichea1thconcernsastheriskassociatedwiththeuseofthosedevicesissignificantforpub1ichea1thandpatientsafety.Itisthereforeappropriatetoadoptcommonspecificationsfo

4、rthosedevicesinrespectofthoserequirements.RegU1atiC)n(EU)2017/746rep1acesDirective98/79/ECoftheEuropeanPar1iamentandoftheCounci10).Thecommontechnica1specificationssetoutinCommissionDecision2002/364/EC()forcertaindevicescoveredbyDirective98/79/ECremainre1evant.Thosecommontechnica1specificationshaveth

5、ereforebeentakenintoaccountandwherenecessaryupdatedtoref1ectthestateoftheart.(3)Toa11owmanufacturers,othereconomicoperators,notifiedbodiesandotheractorstoadapttothisRegu1ation,andtoensureitsproperapp1ication,itisappropriatetodeferitsapp1ication.However,intheinterestofpub1ichea1thandpatientsafety,man

6、ufacturersshou1dbea11owedtocomp1ywiththecommonspecifications1aiddowninthisRegu1ationonavo1untarybasisbeforeitsdateofapp1ication.(4)Toensureacontinuoushigh1eve1ofsafetyandperformanceofdevices,asatransitiona1measureitshou1dbeprovidedthatdevicesthatareinconformitywithDecision2002/364/ECaretobepresumedt

7、obeinconformitywiththerequirementsforcertainperformancecharacteristicssetoutinAnnexItoRegu1ation(EU)2017/746unti1thedateofapp1icationofthisRegu1ation.(5)TheMedica1DeviceCoordinationGrouphasbeenconsu1ted.(6)ThemeasuresprovidedforinthisRegu1ationareinaccordancewiththeopinionoftheCommitteeonMedica1Devi

8、ces,HASADOPTEDTHISREGU1ATION:CommonspecificationsThisRegu1ation1aysdowncommonspecificationsforcertainc1assDinvitrodiagnosticmedica1devicesinrespectoftherequirementsregardingtheperformancecharacteristicssetoutinSection9.1,points(a)and(b),Section9.3andSection9.4,point(a),ofAnnexItoRegu1ation(EU)2017/7

9、46.AnnexI1aysdowncommonspecificationsfordevicescoveredbyAnnexesIItoXIII,asspecifiedinthatAnnex.AnnexII1aysdowncommonspecificationsfordevicesintendedfordetectionofb1oodgroupantigensintheABO,Rh,Ke11,DuffyandKiddb1oodgroupsystems.AnnexIII1aysdowncommonspecificationsfordevicesintendedfordetectionorquant

10、ificationofmarkersofhumanimmunodeficiencyvirus(HIV)infection.AnnexIV1aysdowncommonspecificationsfordevicesintendedfordetectionorquantificationofmarkersofhumanT-ce11Iymphotropicvirus(HT1V)infection.AnnexV1aysdowncommonspecificationsfordevicesintendedfordetectionorquantificationofmarkersofhepatitisCvi

11、rus(HCV)infection.AnnexVI1aysdowncommonspecificationsfordevicesintendedfordetectionorquantificationofmarkersofhepatitisBvirus(HBV)infection.AnnexVII1aysdowncommonspecificationsfordevicesintendedfordetectionorquantificationofmarkersofhepatitisDvirus(HDV)infection.AnnexVIII1aysdowncommonspecifications

12、fordevicesintendedfordetectionofmarkersofvariantCreutzfe1dt-Jakobdisease(vCJD).AnnexIX1aysdowncommonspecificationsfordevicesintendedfordetectionorquantificationofmarkersofcytomega1ovirus(CMV)infection.AnnexX1aysdowncommonspecificationsfordevicesintendedfordetectionorquantificationofmarkersofEpstein-

13、Barrvirusinfection(EBV).AnnexXI1aysdowncommonspecificationsfordevicesintendedfordetectionofmarkersofTreponemapa11iduminfection.AnnexXII1aysdowncommonspecificationsfordevicesintendedfordetectionorquantificationofmarkersofTrypanosomacruziinfection.AnnexXIII1aysdowncommonspecificationsfordevicesintende

14、dfordetectionorquantificationofmarkersofsevereacuterespiratorysyndromecoronavirus2(SARS-CoV-2)infection.DefinitionsForthepurposesofthisRegu1ation,thefo11owingdefinitionsapp1y:(1)/truepositivemeansaspecimenknowntobepositiveforthetargetmarkerandcorrect1yc1assifiedbythedevice;(2)7a1senegativemeansaspec

15、imenknowntobepositiveforthetargetmarkerandmisc1assifiedbythedevice;(3)7a1sepositivemeansaspecimenknowntobenegativeforthetargetmarkerandmisc1assifiedbythedevice;(4)/the1imitofdetection(z1OD,)meansthesma11estamountofthetargetmarkerthatcanbedetected;(5)/nuc1eicacidamp1ificationtechniques(zNAT,)meansmet

16、hodsofdetectionand/orquantificationofnuc1eicacidsbyeitheramp1ificationofatargetsequence,byamp1ificationofasigna1orbyhybridisation;(6)zNATsystem,meansthecombinationofdevicesusedforextraction,amp1ificationanddetectionofnuc1eicacids;(7)7apidtest,meansaqua1itativeorsemi-quantitativeinvitrodiagnosticmedica1device,usedsing1yorinasma11series,whichinvo1vesnon-automatedprocedures(exceptthereadingofresu1ts)andhasbeendesig