体外诊断试剂CE标准.pdf

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1、4.12.2009OfficialENJournaloftheEuropeanUnionL318/25II(ActsadoptedundertheECTreaty/EuratomTreatywhosepublicationisnotobligatory)DECISIONSCOMMISSIONCOMMISSIONDECISIONof27November2009amendingDecision2002/364/EConcommontechnicalspecificationsforinvitrodiagnosticmedicaldevices(notifiedunderdocu

2、mentC(2009)9464)(TextwithEEArelevance)(2009/886/EC)THECOMMISSIONOFTHEEUROPEANCOMMUNITIES,(5)TherequirementsforHIVscreeningassaysshouldbeclarified.Inordertoensurethattheperformancecriteriaappropriatetotoday’stechnologyisreflectedinHavingregardtotheTreatyestablishingtheEuropeanthecommontechn

3、icalspecificationsitisnecessarytoCommunity,addrequirementsforHIVantibody/antigencombinedtestsandfurtherspecificationofthesamplerequirementsforcertainassays.HavingregardtoDirective98/79/ECoftheEuropeanParliamentandoftheCouncilof27October1998onin(6)TheAnnextoDecision2002/364/ECshouldtherefor

4、ebevitro-diagnosticmedicaldevices(1),andinparticulartheamendedaccordinglyand,forthepurposeofclarity,besecondsubparagraphofArticle5(3)thereof,replaced.(7)Duetoanadministrativeerror,CommissionDecisionWhereas:2009/108/ECof3February2009amendingDecision2002/364/EConcommontechnicalspecifications

5、for(1)Thecommontechnicalspecificationsforinvitrodiaginvitro-diagnosticmedicaldevices(3)wasadoptednosticmedicaldevicesarelaiddowninCommissionwithouttheEuropeanParliamentbeinggiventhepossiDecision2002/364/EC(2).bilitytoexerciseitsrightofscrutinyinaccordancewithArticle8ofCouncilDecision1999/4

6、68/ECof28June1999layingdowntheproceduresfortheexerciseof(2)IntheinterestofpublichealthandinordertoreflectimplementingpowersconferredontheCommission(4).technicalprogressincludingtheevolutionintheTherefore,Decision2009/108/ECshouldbereplacedbyperformanceandanalyticalsensitivityofdevices,itis

7、thisDecision.appropriatetorevisethecommontechnicalspecificationslaiddowninDecision2002/364/EC.(8)Manufacturerswhosedevicesarealreadyonthemarketshouldbegivenatransitionalperiodinordertoadapttothenewcommontechnicalspecifications.Ontheother(3)Thedefinitionofrapid