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首页 CouncilDirective9342EECof14June1993(医疗器械法规,MDD)英…

CouncilDirective9342EECof14June1993(医疗器械法规,MDD)英文版.doc

CouncilDirective9342EECof14June…

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2017-06-05 0人阅读 举报 0 0 暂无简介

简介:本文档为《CouncilDirective9342EECof14June1993(医疗器械法规,MDD)英文版doc》,可适用于初中教育领域

COUNCILDIRECTIVEEECofJuneconcerningmedicaldevicesTHECOUNCILOFTHEEUROPEANcommunities,HavingregardtotheTreatyestablishingtheEuropeanEconomicCommunity,andinparticularArticleathereof,HavingregardtotheproposalfromtheCommission(),IncooperationwiththeEuropeanParliament(),HavingregardtotheopinionoftheEconomicandSocialCommittee(),Whereasmeasuresshouldbeadoptedinthecontextoftheinternalmarketwhereastheinternalmarketisanareawithoutinternalfrontiersinwhichthefreemovementofgoods,persons,servicesandcapitalisensuredWhereasthecontentandscopeofthelaws,regulationsandadministrativeprovisionsinforceintheMemberStateswithregardtothesafety,healthprotectionandperformancecharacteristicsofmedicaldevicesaredifferentwhereasthecertificationandinspectionproceduresforsuchdevicesdifferfromoneMemberStatetoanotherwhereassuchdisparitiesconstitutebarrierstotradewithintheCommunityWhereasthenationalprovisionsforthesafetyandhealthprotectionofpatients,usersand,whereappropriate,otherpersons,withregardtotheuseofmedicaldevicesshouldbeharmonizedinordertoguaranteethefreemovementofsuchdeviceswithintheinternalmarketWhereastheharmonizedprovisionsmustbedistinguishedfromthemeasuresadoptedbytheMemberStatestomanagethefundingofpublichealthandsicknessinsuranceschemesrelatingdirectlyorindirectlytosuchdeviceswhereas,therefore,theprovisionsdonotaffecttheabilityoftheMemberStatestoimplementtheabovementionedmeasuresprovidedCommunitylawiscompliedwithWhereasmedicaldevicesshouldprovidepatients,usersandthirdpartieswithahighlevelofprotectionandattaintheperformancelevelsattributedtothembythemanufacturerwhereas,therefore,themaintenanceorimprovementofthelevelofprotectionattainedintheMemberStaresisoneoftheessentialobjectivesofthisDirectiveWhereascertainmedicaldevicesareintendedtoadministermedicinalproductswithinthemeaningofCouncilDirectiveEECofJanuaryontheapproximationofprovisionslaiddownbylaw,regulationoradministrativeactionrelatingtoproprietarymedicinalproducts()whereas,insuchcases,theplacingonthemarketofthemedicaldeviceasageneralruleisgovernedbythepresentDirectiveandtheplacingonthemarketofthemedicinalproductisgovernedbyDirectiveEECwhereasif,however,suchadeviceisplacedonthemarketinsuchawaythatthedeviceandthemedicinalproductformasingleintegralunitwhichisintendedexclusivelyforuseinthegivencombinationandwhichisnotreusable,thatsingleunitproductshallbegovernedbyDirectiveEECwhereasadistinctionmustbedrawnbetweentheabovementioneddevicesandmedicaldevicesincorporating,interalia,substanceswhich,ifusedseparately,maybeconsideredtobeamedicinalsubstancewithinthemeaningofDirectiveEECwhereasinsuchcases,ifthesubstancesincorporatedinthemedicaldevicesareliabletoactuponthebodywithactionancillarytothatofthedevice,theplacingofthedevicesonthemarketisgovernedbythisDirectivewhereas,inthiscontext,thesafety,qualityandusefulnessofthesubstancesmustbeverifiedbyanalogywiththeappropriatemethodsspecifiedinCouncilDirectiveEECofMayontheapproximationofthelawsoftheMemberStatesrelatingtoanalytical,pharmacotoxicologicalandclinicalstandardsandprotocolsinrespectofthetestingofproprietarymedicinalproducts()WhereastheessentialrequirementsandotherrequirementssetoutintheAnnexestothisDirective,includinganyreferenceto'minimizing'or'reducing'riskmustbeinterpretedandappliedinsuchawayastotakeaccountoftechnologyandpracticeexistingatthetimeofdesignandoftechnicalandeconomicalconsiderationscompatiblewithahighlevelofprotectionofhealthandsafetyWhereas,inaccordancewiththeprinciplessetoutintheCouncilresolutionofMayconcerninganewapproachtotechnicalharmonizationandstandardization(),rulesregardingthedesignandmanufactureofmedicaldevicesmustbeconfinedtotheprovisionsrequiredtomeettheessentialrequirementswhereas,becausetheyareessential,suchrequirementsshouldreplacethecorrespondingnationalprovisionswhereastheessentialrequirementsshouldbeappliedwithdiscretiontotakeaccountofthetechnologicallevelexistingatthetimeofdesignandoftechnicalandeconomicconsiderationscompatiblewithahighlevelofprotectionofhealthandsafetyWhereasCouncilDirectiveEECofJuneontheapproximationofthelawsoftheMemberStatesrelatingtoactiveimplantablemedicaldevices()isthefirstcaseofapplicationofthenewapproachtothefieldofmedicaldeviceswhereasintheinterestofuniformCommunityrulesapplicabletoallmedicaldevices,thisDirectiveisbasedlargelyontheprovisionsofDirectiveEECwhereasforthesamereasonsDirectiveEECmustbeamendedtoinsertthegeneralprovisionslaiddowninthisDirectiveWhereastheelectromagneticcompatibilityaspectsformanintegralpartofthesafetyofmedicaldeviceswhereasthisDirectiveshouldcontainspecificrulesonthissubjectwithregardtoCouncilDirectiveEECofMayontheapproximationofthelawsoftheMemberStatesrelatingtoelectromagneticcompatibility()WhereasthisDirectiveshouldincluderequirementsregardingthedesignandmanufactureofdevicesemittingionizingradiationwhereasthisDirectivedoesnotaffecttheauthorizationrequiredbyCouncilDirectiveEuratomofJulyamendingtheDirectiveslayingdownthebasicsafetystandardsforthehealthprotectionofthegeneralpublicandworkersagainstthedangersofionizingradiation(),norapplicationofCouncilDirectiveEuratomofSeptemberlayingdownbasicmeasuresfortheradiationprotectionofpersonsundergoingmedicalexaminationortreatment()whereasCouncilDirectiveEECofJuneontheintroductionofmeasurestoencourageimprovementsinthesafetyandhealthofworkersatwork()andthespecificdirectivesonthesamesubjectshouldcontinuetoapplyWhereas,inordertodemonstrateconformitywiththeessentialrequirementsandtoenableconformitytobeverified,itisdesirabletohaveharmonizedEuropeanstandardstoprotectagainsttherisksassociatedwiththedesign,manufactureandpackagingofmedicaldeviceswhereassuchharmonizedEuropeanstandardsaredrawnupbyprivatelawbodiesandshouldretaintheirstatusasnonmandatorytextswhereas,tothisend,theEuropeanCommitteeforStandardization(CEN)andtheEuropeanCommitteeforElectrotechnicalStandardization(Cenelec)arerecognizedasthecompetentbodiesfortheadoptionofharmonizedstandardsinaccordancewiththegeneralguidelinesoncooperationbetweentheCommissionandthesetwobodiessignedonNovemberWhereas,forthepurposeofthisDirective,aharmonizedstandardisatechnicalspecification(Europeanstandardorharmonizationdocument)adopted,onamandatefromtheCommission,byeitherorbothofthesebodiesinaccordancewithCouncilDirectiveEECofMarchlayingdownaprocedurefortheprovisionofinformationr,thefieldoftechnicalstandardsandregulations(),andpursuanttotheabovementionedgeneralguidelineswhereaswithregardtopossibleamendmentoftheharmonizedstandards,theCommissionshouldbeassistedbytheCommitteesetuppursuanttoDirectiveEECwhereasthemeasurestobetakenmustbedefinedinlinewithprocedureI,aslaiddowninCouncilDecisionEEC()whereas,forspecificfields,whatalreadyexistsintheformofEuropeanPharmacopoeiamonographsshouldbeincorporatedwithintheframeworkofthisDirectivewhereas,therefore,severalEuropeanPharmacopoeiamonographsmaybeconsideredequaltotheabovementionedharmonizedstandardsWhereas,inDecisionEECofDecemberconcerningthemodulesforthevariousphasesoftheconformityassessmentprocedureswhichareintendedtobeusedinthetechnicalharmonizationdirectives(),theCouncilhaslaiddownharmonizedconformityassessmentprocedureswhereastheapplicationofthesemodulestomedicaldevicesenablestheresponsibilityofmanufacturersandnotifiedbodiestobedeterminedduringconformityassessmentproceduresonthebasisofthetypeofdevicesconcernedwhereasthedetailsaddedtothesemodulesarejustifiedbythenatureoftheverificationrequiredformedicaldevicesWhereasitisnecessary,essentiallyforthepurposeoftheconformityassessmentprocedures,togroupthedevicesintofourproductclasseswhereastheclassificationrulesarebasedonthevulnerabilityofthehumanbodytakingaccountofthepotential第三页

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CouncilDirective9342EECof14June1993(医疗器械法规,MDD)英文版

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