MDD指令9342EEC(中英文对照版最终版)

第1页共72页EditedByStephenLing.Anyquestion,pleasecontactwithmeViaEmail:ibat@163.comCOUNCILDIRECTIVE93/42/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 财务内部控制制度的内容财务内部控制制度的内容人员招聘与配置的内容项目成本控制的内容消防安全演练内容 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EditedByStephenLing.Anyquestion,pleasecontactwithmeViaEmail:ibat@163.comWhereascertainmedicaldevicesareintendedtoadministermedicinalproductswithinthemeaningofCouncilDirective65/65/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;whereastheessentialrequirementsshouldbeappliedwithdiscretiontotakeaccountofthetechnologicallevelexistingatthetimeofdesignandoftechnicalandeconomicconsiderationscompatiblewithahighlevelofprotectionofhealthandsafety;鉴于基本要求的落实应谨慎考虑设计当时的科技水准,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;WhereasCouncilDirective90/385/EECof20June1990ontheapproximationofthelawsoftheMemberStatesrelatingtoactiveimplantablemedicaldevicesisthefirstcaseofapplicationofthenewapproachtothefieldofmedicaldevices;whereasintheinterestofuniformCommunityrulesapplicabletoallmedicaldevices,thisDirectiveisbasedlargelyontheprovisionsofDirective90/385/EEC;whereasforthesamereasonsDirective90/385/EECmustbeamendedtoinsertthegeneralprovisionslaiddowninthisDirective;第3页共72页EditedByStephenLing.Anyquestion,pleasecontactwithmeViaEmail:ibat@163.com鉴于1990年6月20日通过的90/385/EEC号[各会员国有关主动植入式医疗器械法律调和]的理事会指令是第一个应用在医疗器械方面的新方法指令;鉴于为使共同体规定适用于所有的医疗器械,本指令基本上是以90/385/EEC号指令的条款为依据;鉴于90/385/EEC号指令,因此也必须增加本指令所列的一般条款的部分;Whereastheelectromagneticcompatibilityaspectsformanintegralpartofthesafetyofmedicaldevices;whereasthisDirectiveshouldcontainspecificrulesonthissubjectwithregardtoCouncilDirective89/336/EECof3May1989ontheapproximationofthelawsoftheMemberStatesrelatingtoelectromagneticcompatibility;鉴于医疗器械的电磁相容性是整个产品安全的一部分;鉴于本指令因此须包括1989年5月3日89/336/EEC号[各会员国有关电磁相容性法律调和]的理事会指令中所制订的特定规定;WhereasthisDirectiveshouldincluderequirementsregardingthedesignandmanufactureofdevicesemittingionizingradiation;whereasthisDirectivedoesnotaffecttheauthorizationrequiredbyCouncilDirective80/836/Euratomof15July1980amendingtheDirectiveslayingdownthebasicsafetystandardsforthehealthprotectionofthegeneralpublicandworkersagainstthedangersofionizingradiation,norapplicationofCouncilDirective84/466/Euratomof3September1984layingdownbasicmeasuresfortheradiationprotectionofpersonsundergoingmedicalexaminationortreatment;whereasCouncilDirective89/391/EECof12June1989ontheintroductionofmeasurestoencourageimprovementsinthesafetyandhealthofworkersatworkandthespecificdirectivesonthesamesubjectshouldcontinuetoapply;鉴于本指令应包含释放电离辐射医疗器械设计及制造的相关要求;鉴于本指令不影响1980年7月15日80/836/Euratom理事会指令所需要的授权,该指令目的在修订为保护大众及工作人员健康,防止电离辐射危险而制订基本安全标准的其他指令;本指令亦不影响1984年9月3日84/466/Euratom号[制订保护人员在医疗检查或治疗中不受辐射影响的基本方法]理事会指令的适用;鉴于1989年6月12日89/391/EEC号理事会指令[鼓励改善工作场所中工人的安全与健康]及其他相关主题的指令应持续适用;Whereas,inordertodemonstrateconformitywiththeessentialrequirementsandtoenableconformitytobeverified,itisdesirabletohaveharmonizedEuropeanstandardstoprotectagainsttherisksassociatedwiththedesign,manufactureandpackagingofmedicaldevices;whereassuchharmonizedEuropeanstandardsaredrawnupbyprivate-lawbodiesandshouldretaintheirstatusasnon-mandatorytexts;whereas,tothisend,theEuropeanCommitteeforStandardization(CEN)andtheEuropeanCommitteeforElectrotechnicalStandardization(Cenelec)arerecognizedasthecompetentbodiesfortheadoptionofharmonizedstandardsinaccordancewiththegeneralguidelinesoncooperationbetweentheCommissionandthesetwobodiessignedon13November1984;鉴于为证明符合基本要求并使该符合性得以落实,有必要建立调和的欧洲标准,以避免医疗器械在设计,制造及包装上所可能带来的危险,鉴于调和的欧洲标准由私人立法机构制订,而且应维持自愿性质;鉴于欧洲标准化委员会(CEN)及欧洲电工标准化委员会(CENELEC)被认为是制订调和标准有能力的团体(competentbodies),而此标准符合1984年11月13日执委会与上述两团体所签订的合作纲要为基础的一般指导原则;Whereas,forthepurposeofthisDirective,aharmonizedstandardisatechnicalspecification(Europeanstandardorharmonizationdocument)adopted,onamandatefromtheCommission,byeitherorbothofthesebodiesinaccordancewithCouncilDirective83/189/EECof28March1983layingdownaprocedurefortheprovisionofinformationinthefieldoftechnicalstandardsandregulations,andpursuanttotheabovementionedgeneralguidelines;whereaswithregardtopossibleamendmentoftheharmonizedstandards,theCommissionshouldbeassistedbytheCommitteesetuppursuanttoDirective83/189/EEC;whereasthemeasurestobetakenmustbedefinedinlinewithprocedureI,aslaiddowninCouncilDecision87/373/EEC;whereas,forspecificfields,whatalreadyexistsintheformofEuropeanPharmacopoeiamonographsshouldbeincorporatedwithintheframeworkofthisDirective;whereas,therefore,severalEuropeanPharmacopoeiamonographsmaybeconsideredequaltotheabovementionedharmonizedstandards;鉴于为达本指令目的,调和标准是前述机构接获理事会命令后,依理事会1983年3月28日通过的83/189/EEC号指令[有关制订技术标准及法规资讯提供的程序]而采纳的技术规范(欧洲标准或调和文件,符合前述一般纲要的规定;鉴于调和标准的修正有赖于83/189/EE号指令建立的委员会的协助;鉴于应采取的措施须依照理事会87/378/EEC号指令第4页共72页EditedByStephenLing.Anyquestion,pleasecontactwithmeViaEmail:ibat@163.com程序一的规定;鉴于特殊领域中现存的欧洲药典专题 论文 政研论文下载论文大学下载论文大学下载关于长拳的论文浙大论文封面下载 应纳入本指令的架构中;因此数篇欧洲药典专题论文将视其与前述调和标准有着同等的效力;Whereas,inDecision90/683/EECof13December1990concerningthemodulesforthevariousphasesoftheconformityassessmentprocedureswhichareintendedtobeusedinthetechnicalharmonizationdirectives,theCouncilhaslaiddownharmonizedconformityassessmentprocedures;whereastheapplicationofthesemodulestomedicaldevicesenablestheresponsibilityofmanufacturersandnotifiedbodiestobedeterminedduringconformityassessmentproceduresonthebasisofthetypeofdevicesconcerned;whereasthedetailsaddedtothesemodulesarejustifiedbythenatureoftheverificationrequiredformedicaldevices;鉴于理事会在1990年12月13日通过的90/683/EEC号[有关技术调和指令适用的符合评鉴程序各阶段模式]决定中制定调和的符合评鉴程序;鉴于这些模式于医疗器械的应用,可以依相关器械的型式决定制造商及公告机构在符合评鉴程序中应负的责任;鉴于医疗器械的证明有必要在模式里增加细节的规定;Whereasitisnecessary,essentiallyforthepurposeoftheconformityassessmentprocedures,togroupthedevicesintofourproductclasses;whereastheclassificationrulesarebasedonthevulnerabilityofthehumanbodytakingaccountofthepotentialrisksassociatedwiththetechnicaldesignandmanufactureofthedevices;whereastheconformityassessmentproceduresforClassIdevicescanbecarriedout,asageneralrule,underthesoleresponsibilityofthemanufacturersinviewofthelowlevelofvulnerabilityassociatedwiththeseproducts;whereas,forClassIIadevices,theinterventionofanotifiedbodyshouldbecompulsoryattheproductionstage;whereas,fordevicesfallingwithinClassesIIbandIIIwhichconstituteahighriskpotential,inspectionbyanotifiedbodyisrequiredwithregardtothedesignandmanufactureofthedevices;whereasClassIIIissetasideforthemostcriticaldevicesforwhichexplicitpriorauthorizationwithregardtoconformityisrequiredforthemtobeplacedonthemarket;鉴于为达到符合评鉴的目的有必要将医疗器械分为四类;鉴于分类是以考虑器械的技术设计及制造对易受伤的人体可能带来的危险程度为原则;鉴于第I类医疗器械对人体可能产生的伤害较轻微,其符合性评鉴程序大致可由制造商完全负责执行;鉴于对第II(a)类医疗器械而言,在生产阶段时公告机构的介入应属强制性质;鉴于属于第II(b)类及第III类的医疗器械对人体具有较高的潜在危险,因此在器械的设计及制造阶段必须有公告机构的检验;鉴于第III类的器械皆为较特别的器械,其一致性需在上市的前获得明确授权;Whereasincaseswheretheconformityofthedevicescanbeassessedundertheresponsibilityofthemanufacturerthecompetentauthoritiesmustbeable,particularlyinemergencies,tocontactapersonresponsibleforplacingthedeviceonthemarketandestablishedintheCommunity,whetherthemanufactureroranotherpersonestablishedintheCommunityanddesignatedbythemanufacturerforthepurpose;鉴于器械的一致性如能由制造商负责评鉴,相关主管机关,特别是紧急状况时,应能联络到一位设于共同体内负责将器械在市场上销售的人员,该人员可以是制造商本人或其他设于共同体内经制造商授权的人员;Whereasmedicaldevicesshould,asageneralrule,beartheCEmarktoindicatetheirconformitywiththeprovisionsofthisDirectivetoenablethemtomovefreelywithintheCommunityandtobeputintoserviceinaccordancewiththeirintendedpurpose;鉴于医疗器械应附加CE标志,表示其符合本指令的条款,而得以在共同体市场上自由流通并依其设计的目的使用;Whereas,inthefightagainstAIDSandinthelightoftheconclusionsoftheCounciladoptedon16May1989regardingfutureactivitiesonAIDSpreventionandcontrolatCommunitylevel,medicaldevicesusedforprotectionagainsttheHIVvirusmustaffordahighlevelofprotection;whereasthedesignandmanufactureofsuchproductsshouldbeverifiedbyanotifiedbody;鉴于为抵抗爱滋病,并顾及理事会于1989年5月16日采纳有关共同体层次未来防止暨控制爱滋病相关活动的结论,用于防止HIV病毒感染的医疗器械应提供人体高度的保护;此类产品的设计及制造应由公告机构的证实;Whereastheclassificationrulesgenerallyenablemedicaldevicestobeappropriatelyclassified;whereas,inviewofthediversenatureofthedevicesandtechnologicalprogressinthisfield,stepsmustbetakentoincludeamongsttheimplementingpowersconferredontheCommissionthedecisionstobetakenwithregardtotheproperclassificationorreclassificationofthedevicesor,whereappropriate,theadjustmentoftheclassificationrulesthemselves;第5页共72页EditedByStephenLing.Anyquestion,pleasecontactwithmeViaEmail:ibat@163.comwhereassincetheseissuesarecloselyconnectedwiththeprotectionofhealth,itisappropriatethatthesedecisionsshouldcomeunderprocedureIIIa,asprovidedforinDirective87/373/EEC;鉴于前述的分类原则大多可以适当地将医疗器械分类;鉴于医疗器械性质及相关领域技术进步的性质各异,因此必须采取一些措施以决定授予执委会的执行权力及有关器械的分类或再分类,或者于适当时调整分类的原则;鉴于上述的问题与人员健康的保护有着密切的关联,因此这些决议应依照87/373/EEC号指令程序IIIa规定;Whereastheconfirmationofcomplicancewiththeessentialrequirementsmaymeanthatclinicalinvestigationshavetobecarriedoutundertheresponsibilityofthemanufacturer;whereas,forthepurposeofcarryingouttheclinicalinvestigations,appropriatemeanshavetobespecifiedfortheprotectionofpublichealthandpublicorder;鉴于制造商有责任执行临床调查以证明其医疗器械符合安全要求;因此为保证大众健康及秩序应明订执行临床调查的适当方法;WhereastheprotectionofhealthandtheassociatedcontrolsmaybemademoreeffectivebymeansofmedicaldevicevigilancesystemswhichareintegratedatCommunitylevel;鉴于健康的保护及相关的管制方法以在共同体层次上建立一个医疗装置警戒系统为最有效;WhereasthisDirectivecoversthemedicaldevicesreferredtoinCouncilDirective76/764/EECof27July1976ontheapproximationofthelawsoftheMemberStatesonclinicalmercury-in-glass,maximumreadingthermometers;whereastheabovementionedDirectivemustthereforeberepealed;whereasforthesamereasonsCouncilDirective84/539/EECon17September1984ontheapproximationofthelawsoftheMemberStatesrelatingtoelectro-medicalequipmentusedinhumanorveterinarymedicinemustbeamended,鉴于理事会于1976年7月27日通过76/764/EEC号[有关各会员国水银玻璃最高温度计法律调和]的指令中所提及的医疗器械亦受本指令规范;前述指令因此必须撤销;基于同样原因,理事会1984年9月17日通过的84/539/EEC号指令[有关各会员国人类或动物医疗使用的电动医疗器械法律调和],HASADOPTEDTHISDlRECTIVE:爰制订本指令:Article1第1条Definitions,scope定义,范围1.ThisDirectiveshallapplytomedicaldevicesandtheiraccessories.ForthepurposesofthisDirective,accessoriesshallbetreatedasmedicaldevicesintheirownright.Bothmedicaldevicesandaccessoriesshallhereinafterbetermeddevices.本指令适用于医疗器械及其附属物.附属物在本指令的适用范围内亦视其为医疗器械.两者以下皆称器械.2.ForthepurposesofthisDirective,thefollowingdefinitionsshallapply:为本指令的目地,下列定义适用于:(a)medicaldevice'meansanyinstrument,apparatus,appliance,materialorotherarticle,whetherusedaloneorincombination,includingthesoftwarenecessaryforitsproperapplicationintendedbythemanufacturertobeusedforhumanbeingsforthepurposeof:[医疗器械]是指制造商设计供人类于下列情况,不论是单独或合并使用的仪器,设备,器械, 材料 关于××同志的政审材料调查表环保先进个人材料国家普通话测试材料农民专业合作社注销四查四问剖析材料 或其他物品,包括适当应用所需的软体,而此种应用是厂商为人们下列的目地而订定:-diagnosis,prevention,monitoring,treatmentoralleviationofdisease,诊断,预防,追踪,治疗或减轻疾病,-diagnosis,monitoring,treatment,alleviationoforcompensationforaninjuryorhandicap,第6页共72页EditedByStephenLing.Anyquestion,pleasecontactwithmeViaEmail:ibat@163.com诊断,追踪,治疗或修整伤处或残障部位,-investigation,replacementormodificationoftheanatomyorofaphysiologicalprocess,解剖或生理过程中的检查,换置或修正,-controlofconception,生育控制,andwhichdoesnotachieveitsprincipalintendedactioninoronthehumanbodybypharmacological,immunologicalormetabolicmeans,butwhichmaybeassistedinitsfunctionbysuchmeans;这些器械不可借药性,免疫力或新陈代谢的方法在人体内达到其主要设计的目的,但可用这些器械辅助其功能者;(b)'accessory'meansanarticlewhichwhilstnotbeingadeviceisintendedspecificallybyitsmanufacturertobeusedtogetherwithadevicetoenableittobeusedinaccordancewiththeuseofthedeviceintendedbythemanufacturerofthedevice;[附属物]是指本身不可独立使用的器械,制造商设计附属件的目地是配合其他器械合并使用,使该器械得以依其设计目地发生功用;(c)'deviceusedforinvitrodiagnosis'meansanydevicewhichisareagent,reagentproduct,kit,instrument,equipmentorsystem,whetherusedaloneorincombination,intendedbythemanufacturertobeusedinvitrofortheexaminationofsamplesderivedfromthehumanbodywithaviewtoprovidinginformationonthephysiologicalstate,stateofhealthordisease,orcongenitalabnormalitythereof;[体外诊断用器械]是指任何自成单位或与其他物件组合的任何试剂,试剂品,套装用具,仪器,设备或系统形态的器械.这种器械是制造商设计作为检查人体组织标本用的器械,以期能够提供有关其生理状况,健康或生病或任何先天不正常等讯息;(d)'custom-madedevice'meansanydevicespecificallymadeinaccordancewithadulyqualifiedmedicalpractitioner'swrittenprescriptionwhichgives,underhisresponsibility,specificdesigncharacteristicsandisintendedforthesoleuseofaparticularpatient.[订制的器械]是指依照合格医疗从业人员描述的特色而特别制作的器械,该器械是为特定病患设计且专供该病患使用.Theabovementionedprescriptionmayalsobemadeoutbyanyotherpersonauthorizedbyvirtueofhisprofessionalqualificationstodoso.前述的描述可以由专业资格而获授权的其他人提供.Mass-produceddeviceswhichneedtobeadaptedtomeetthespecificrequirementsofthemedicalpractitioneror.anyotherprofessionaluserarenotconsideredtobecustom-madedevices;但订制的器械不包括那些为满足医疗人员或其他专业使用人要求而改装且大量生产的器械.(e)'deviceintendedforclinicalinvestigation'meansanydeviceintendedforusebyadulyqualifiedmedicalpractitionerwhenconductinginvestigationsasreferredtoinSection2.1ofAnnexXinanadequatehumanclinicalenvironment.[临床调查用的器械]是指由适当的合格医疗从医人员在适当的人类临床环境中,执行附录十第2.1.所述的调查时所使用的任何器械.Forthepurposeofconductingclinicalinvestigation,anyotherpersonwho,byvirtueofhisprofessionalqualifications,isauthorizedtocarryoutsuchinvestigationshallbeacceptedasequivalenttoadulyqualifiedmedicalpractitioner;其他具专业资格的人员经授权执行此种临床调查将视同合格医疗从事人员所执行的临床调查;(f)'manufacturer'meansthenaturalorlegalpersonwithresponsibilityforthedesign,manufacture,packagingandlabellingofadevicebeforeitisplacedonthemarketunderhisownname,regardlessofwhethertheseoperationsarecarriedoutbythatpersonhimselforonhisbehalfbyathirdparty.第7页共72页EditedByStephenLing.Anyquestion,pleasecontactwithmeViaEmail:ibat@163.com[制造商]是指器械以其名称上市前,负责器械的设计,制造,包装及贴附标签的自然人或法人,无论这些设计,制造等过程是否为自然人或法人亲自执行或委托第三者执行.TheobligationsofthisDirectivetobemetbymanufacturersalsoapplytothenaturalorlegalpersonwhoassembles,packages,processes,fullrefurbishesand/orlabelsoneormoreready-madeproductsand/orassignstothemtheirintendedpurposeasadevicewithaviewtotheirbeingplacedonthemarketunderhisownname.Thissubparagraphdoesnotapplytothepersonwho,whilenotamanufacturerwithinthemeaningofthefirstsubparagraph,assemblesoradaptsdevicesalreadyonthemarkettotheirintendedpurposeforanindividualpatient;本指令所规定有关制造商的责任亦适用于将一个或一个以上现成的产品加以组装,包装,加工,重新处理及/或附加标签而成一器械,指定其用途并准备以其名称命名上市的自然人或法人.对于那些非属前一段制造商定义者,为个别病患的需要拼装或改装已上市销售的器械的情形不适用本段的规定;(g)'intendedpurpose'meanstheuseforwhichthedeviceisintendedaccordingtothedatasuppliedbythemanufactureronthelabelling,intheinstructionsand/orinpromotionalmaterials;[预期的用途]是指器械须依照制造商于标签上,说明书及/或促销宣称中提供的使用条件及资料;(h)'placingonthemarket'meansthefirstmakingavailableinreturnforpaymentorfreeofchargeofadeviceotherthanadeviceintendedforclinicalinvestigation,withaviewtodistributionand/oruseontheCommunitymarket,regardlessofwhetheritisneworfullyrefurbished;[上市]是指为大量行销及/或于共同体市场使用的目的,首次以金钱交易或免费赠送方式提供非临床调查用全新或重新处理过的器械的行为;(i)'puttingintoservice'meansthestageatwhichadeviceisreadyforuseontheCommunitymarketforthefirsttimeforitsintendedpurpose.[开始使用]是指某一器械在共同体市场首次可依原订的用途开始使用的时期.3.WhereadeviceisintendedtoadministeramedicinalproductwithinthemeaningofArticle1ofDirective65/65/EEC,thatdeviceshallbegovernedbythepresentDirective,withoutprejudicetotheprovisionsofDirective'65/65/EECwithregardtothemedicinalproduct.对于用来管理65/65/EEC号指令第一条定义的医疗产品的器械,在不侵害65/65/EEC号有关医疗产品指令条款的规定下,该类器械应受本指令规范.If,however,suchadeviceisplacedonthemarketinsuchawaythatthedeviceandthemedicinalproductformasingleintegralproductwhichisintendedexclusivelyforuseinthegivencombinationandwhichisnotreusable,thatsingleproductshallbegovernedbyDirective65/65/EEC.TherelevantessentialrequirementsofAnnexItothepresentDirectiveshallapplyasfarassafetyandperformancerelateddevicefeaturesareconcerned.但是,假若某种器械须与其他医疗产品组合成一完整的产品而上市销售使用,且无法二次使用时,该组合产品应受65/65/EEC号指令规范.本指令附录一所列有关器械安全及性能方面的相关基本要求仍然适用.4.Whereadeviceincorporates,asanintegralpart,asubstancewhich,ifusedseparately,maybeconsideredtobeamedicinalproductwithinthemeaningofArticle1ofDirective65/65/EEC