IVDR Class D类通用规范CS（英文）.docx

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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-quantitativeinvitrodiagnosticmedicaldevice,usedsinglyorinasmallseries,whichinvolvesnon-automatedprocedures(exceptthereadingofr