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第1页共72页COUNCILDIRECTIVE93/42/EECof14June19931993年6月14日理事会第93/42/EEC号指令concerningmedicaldevices关于医疗器械THECOUNCILOFTHEEUROPEANCOMMUNITIES,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配合欧洲议会HavingregardtotheopinionoftheEconomicandSocialCommittee,依据经济暨社会委员会的意见Whereasmeasuresshouldbeadoptedinthecontextoftheinternalmarket;whereastheinternalmarketisanareawithoutinternalfrontiersinwhichthefreemovementofgoods,persons,servicesandcapitalisensured;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;whereasthecertificationandinspectionproceduresforsuchdevicesdifferfromoneMemberStatetoanother;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;Whereasthenationalprovisionsforthesafetyandhealthprotectionofpatients,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;WhereastheharmonizedprovisionsmustbedistinguishedfromthemeasuresadoptedbytheMemberStatestomanagethefundingofpublichealthandsicknessinsuranceschemesrelatingdirectlyorindirectlytosuchdevices;whereas,therefore,theprovisionsdonotaffecttheabilityoftheMemberStatestoimplementtheabovementionedmeasuresprovidedCommunitylawiscompliedwith;鉴于调和的规定必然与各会员国采取的部分措施有所不同,这些措施是为筹措公共健康与疾病保险计划的基金,且直接或间接与医疗器械有关;鉴于共同体若与上述措施相符,则这些规定并不影响会员国落实上述措施的能力;Whereasmedicaldevicesshouldprovidepatients,usersandthirdpartieswithahighlevelofprotectionandattaintheperformancelevelsattributedtothembythemanufacturer;whereas,therefore,themaintenanceorimprovementofthelevelofprotectionattainedintheMemberStatesisoneoftheessentialobjectivesofthisDirective;鉴于医疗器械应提供病患,使用者及第三者高度的保护,且应该达到厂商所要求的性能水准;鉴于维持或改进各会员国对病患等保护的程度乃本指令目的的一;第2页共72页WhereascertainmedicaldevicesareintendedtoadministermedicinalproductswithinthemeaningofCouncilDirective65/65/EECof26January1965ontheapproximationofprovisionslaiddownbylaw,regulationoradministrativeactionrelatingtoproprietarymedicinalproducts;whereas,insuchcases,theplacingonthemarketofthemedicaldeviceasageneralruleisgovernedbythepresentDirectiveandtheplacingonthemarketofthemedicinalproductisgovernedbyDirective65/65/EEC;whereasif,however,suchadeviceisplacedonthemarketinsuchawaythatthedeviceandthemedicinalproductformasingleintegralunitwhichisintendedexclusivelyforuseinthegivencombinationandwhichisnotreusable,thatsingle-unitproductshallbegovernedbyDirective65/65/EEC;whereasadistinctionmustbedrawnbetweentheabovementioneddevicesandmedicaldevicesincorporating,interalia,substanceswhich,ifusedseparately,maybeconsideredtobeamedicinalsubstancewithinthemeaningofDirective65/65/EEC;whereasinsuchcases,ifthesubstancesincorporatedinthemedicaldevicesareliabletoactuponthebodywithactionancillarytothatofthedevice,theplacingofthedevicesonthemarketisgovernedbythisDirective;whereas,inthiscontext,thesafety,qualityandusefulnessofthesubstancesmustbeverifiedbyanalogywiththeappropriatemethodsspecifiedinCouncilDirective75/318/EECof20May1975ontheapproximationofthelawsoftheMemberStatesrelatingtoanalytical,pharmaco-toxicologicalandclinicalstandardsandprotocolsinrespectofthetestingofproprietarymedicinalproducts;鉴于部分医疗器械是符合1965年1月26日理事会第65/65/EEC号指令,与专卖医药产品有关的法律,法规或管理行为所订的实施规定,鉴于医疗器械的上市基本上由本指令规范,但医疗产品的上市则受65/65/EEC号指令规范;鉴于若有某种器械须与其他医疗产品组成一完整的产品而上市销售,使用,且无法二次使用时,则该组合产品应受65/65/EEC号指令规范;鉴于前述的医疗器械和包含医疗物质且该物质单独使用时符合65/65/EEC号指令规定的医疗器械应加以区别;鉴于前述包含于医疗器械的医疗物质若对人体产生作用以辅助医疗器械的作用时,则该医疗器械的上市应由本指令规范;鉴于1975年5月20日75/318/EEC号理事会指令[制定各会员国在测试专利医疗产品方面有关分析药物毒性和临床的标准及调查书的法律调和],医疗物质的安全,品质及效用在前述情况下则须依该指令明定的适当方法加以证实;WhereastheessentialrequirementsandotherrequirementssetoutintheAnnexestothisDirective,includinganyreferenceto'minimizing'or'reducing'riskmustbeinterpretedandappliedinsuchawayastotakeaccountoftechnologyandpracticeexistingatthetimeofdesignandoftechnicalandeconomicalconsiderationscompatiblewithahighlevelofprotectionofhealthandsafety;鉴于本指令附录所订的基本要求及其他要求,包括[最低]或[降低]危险部分的应用,应考虑设计当时的科技及实施情形,并在符合健康和安全高度保护的原则下考虑技术及经济的因素;Whereas,inaccordancewiththeprinciplessetoutintheCouncilresolutionof7May1985concerninganewapproachtotechnicalharmonizationandstandardization,rulesregardingthedesignandmanufactureofmedicaldevicesmustbeconfinedtotheprovisionsrequiredtomeettheessentialrequirements;whereas,becausetheyareessential,suchrequirementsshouldreplacethecorrespondingnationalprovisions;鉴于为符合1985年5月7日理事会决议中有关技术调和与标准化新方针所订定的原则,有关医疗器械的设计及执照应遵守相关条款以符合基本要求;鉴于这些要求属基本要求,所以应取代对应的国家规定;whereastheessentialrequirementsshouldbeappliedwithdiscretiontotakeaccountofthetechnologicallevelexistingatthetimeofdesignandoftechnicalandec