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1、COUNCILDIRECTIVEconcerningmedicaldevices关于医疗器械更改历史记录：lM1Directive98/79/ECoftheEuropeanParliamentandoftheCouncilofL33117.12.199827October1998lM2Directive2000/70/ECoftheEuropeanParliamentandoftheCouncilofL3132213.12.200016November2000lM3Directive2001/104/ECo
2、ftheEuropeanParliamentandoftheCouncilL65010.1.2002of7December2001lM4Regulation(EC)No1882/2003oftheEuropeanParliamentandoftheL284131.10.2003Councilof29September2003lM5Directive2007/47/ECoftheEuropeanParliamentandoftheCouncilofL2472121.9.20075September2007TH
3、ECOUNCILOFTHEEUROPEANCOMMUNITIES,欧洲共同体理事会HavingregardtotheTreatyestablishingtheEuropeanEconomicCommunity,andinparticularArticle100athereof,依据欧洲经济体所制订的罗马条约,特别是第100a条规定HavingregardtotheproposalfromtheCommission依据执委会的建议案IncooperationwiththeEuropeanParliament配
4、合欧洲议会HavingregardtotheopinionoftheEconomicandSocialCommittee,依据经济暨社会委员会的意见Whereasmeasuresshouldbeadoptedinthecontextoftheinternalmarket;whereastheinternalmarketisanareawithoutinternalfrontiersinwhichthefreemovementofgoods,persons,servicesandcapitalisensure
5、d;鉴于内部市场的完成应采取一些措施;鉴于内部市场是一无内部疆界的区域,区域内的货物,人员,服务及资金应可自由流通Whereasthecontentandscopeofthelaws,regulationsandadministrativeprovisionsinforceintheMemberStateswithregardtothesafety,healthprotectionandperformancecharacteristicsofmedicaldevicesaredifferent;wherea
6、sthecertificationandinspectionproceduresforsuchdevicesdifferfromoneMemberStatetoanother;whereassuchdisparitiesconstitutebarrierstotradewithintheCommunity;鉴于各会员国间现存有关医疗器械的安全,对健康的保护及使用特性方面的法律,法规及行政命令的内容与范围不尽相同;鉴于各会员国对此器械的验证及检验程序也不相同;鉴于前述的分歧将阻碍共同体内的贸易活动;Where
7、asthenationalprovisionsforthesafetyandhealthprotectionofpatients,usersand,whereappropriate,otherpersons,withregardtotheuseofmedicaldevicesshouldbeharmonizedinordertoguaranteethefreemovementofsuchdeviceswithintheinternalmarkert;鉴于医疗器械的使用对病患,使用者,甚至其他人有关安全及健康
8、保护的相关国家规定应加以调和,以保证此类器械在内部市场能自由流通;WhereastheharmonizedprovisionsmustbedistinguishedfromthemeasuresadoptedbytheMemberStatestomanagethefundingofpublichealthandsicknessinsuranceschemesrelatingdirectlyorindirectly
