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欧盟CE认证最新静态.ppt

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欧盟CE认证最新动态什么是CE标志(标记)?欧洲医疗器械指令更改的分析2.Recordsmustberetainedfor5+yearsRecordsmustnowbemaintainedforinspectionbytheCompetentAuthoritiesfortheusefullifeoftheproductor5yearsfromdateofmanufacture,whicheverisgreater.Forimplantabledevices,recordsneedtobekeptfor15yearsfromthetimethelastproductwasmanufactured.3.ClassI(SterileandMeasuring)devicesmaynowchooseAnnexIIClassISterileandMeasuringdeviceswillhavemoreflexibilitytoselectaroutetocomplianceastheywillbegiventheoptiontoselectafullqualityassuranceconformityassessmentmodule. 4.OutsourceddesignandmanufacturingmustbemorecloselymonitoredIfthedesignormanufacturingofadeviceisdonebyathirdparty,youmustdemonstratethatyouhaveadequatecontrolsinplacetoensurethecontinuedefficientoperationofthesupplier'squalitysystem.5.CloserinspectionofdesigndocumentationNotifiedBodieswillberequiredtoperformaninspectionofdesigndocumentationforarepresentativesampleofdevicesusingindustrystandardstatisticaltechniquesandcommensuratewiththeriskofthedevice. 6.AppointmentofanAuthorizedRepresentative(AR)explicitlynotedTheARgetsamandatetoact,andbecontacted,inlieuofthemanufacturerintermsofmeetingtheobligationsbytheDirectivesforallclassesofdevices.7.SoftwareisnowclearlydefinedasanactivemedicaldeviceItdoesnotmatterwhetherthesoftwareisintegralwiththedeviceorisastandaloneproduct.SoftwarevalidationwillalsobeanEssentialRequirement. 8.CustomdevicesnowsubjecttopostmarketsurveillanceCustomdeviceswillnowrequireapost-marketsurveillancesystemthatisreportabletoCompetentAuthorities.9.InstructionsforUse(IFU)mustnowberevisioncontrolledWhereappropriate,thenewDirectivestatesthatthedateofissueorlatestrevisionoftheIFUmustbeclearlyindicated. 10.BorderlineproductsWhetheraproductisclassifiedasamedicinalproductordevicewillnowbedeterminedbythePrimaryModeofActionratherthanbytheIntendedUse! 11.DefinitionofcentralcirculatorysystemhasbeenexpandedNowincludesthevesselsaorticarch(arcusaortae)anddescendingaorta(aortadescendens)totheaorticbifurcation(bifurcatioaortae).Anydevicesthatcomeincontactw