EEC完整版中英文对照.doc

COUNCIL DIRECTIVE concerning medical devices关于医疗器械更改历史记录：l M1Directive 98/79/EC of the European Parliament and of the Council of L 331 1 7.12.1998 27 October 1998l M2Directive 2000/70/EC of the European Parliament and of the Council of L 313 22 13.12.200016 November 2000l M3Directive 2001/104/EC of the European Parliament and of the Council L 6 50 10.1.2002of 7 December 2001l M4Regulation (EC) No 1882/2003 of the European Parliament and of the L 284 1 31.10.2003Council of 29 September 2003l M5Directive 2007/47/EC of the European Parliament and of the Council of L 247 21 21.9.20075 September 2007THE COUNCIL OF THE EUROPEAN COMMUNITIES,欧洲共同体理事会Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,依据欧洲经济体所制订的罗马条约, 特别是第 100a 条规定Having regard to the proposal from the Commission 依据执委会的建议案In cooperation with the European Parliament配合欧洲议会Having regard to the opinion of the Economic and Social Committee, 依据经济暨社会委员会的意见Whereas measures should be adopted in the context of the internal market; whereas the internal market is an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured;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Whereas the content and scope of the laws, regulations and administrative provisions in force in the Member States with regard to the safety, health protection and performance characteristics of medical devices are different; whereas the certification and inspection procedures for such devices differ from one Member State to another; whereas such disparities constitute barriers to trade within the Community;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;Whereas the national provisions for the safety and health protection of patients, users and, where appropriate, other persons, with regard to the use of medical devices should be harmonized in order to guarantee the free movement of such devices within the internal markert;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;Whereas the harmonized provisions must be distinguished from the measures adopted by the Member States to manage the funding of public health and sickness insurance schemes relating directly or indirectly to such devices; whereas, therefore, the provisions do not affect the ability of the Member States to implement the abovementioned measures provided Community law is complied with;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;Whereas medical devices should provide patients, users and third parties with a high level of protection and attain the performance levels attributed to them by the manufacturer; whereas, therefore, the maintenance or improvementof the level of protection attained in the Member States is one of the essential objectives of this Directive;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;Whereas certain medical devices are intended to administer medicinal products within the meaning of CouncilDirective 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products; whereas, in such cases, the placing on the market of the medical device as a general rule is governed by the present Directive and the placing on the market of the medicinal product is governed by Directive 65/65/EEC; whereas if, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral unit which is intended exclusively for use in the given combination and which is not reusable, that single-unit product shall be governed by Directive 65/65/EEC; whereas a distinction must be drawn between the abovementioned devices and medical devices incorporating, inter alia, substances which, if used separately, may be considered to be a medicinal substance within the meaning of Directive 65/65/EEC; whereas in such cases, if the substances incorporated in the medical devices are liable to act upon the body with action ancillary to that of the device, the placing of the devices on the market is governed by this Directive; whereas, in this context, the safety, quality and usefulness of the substances must be verified by analogy with the appropriate methods specified in Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to analytical pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products;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;Whereas the essential requirements and other requirements set out in the Annexes to this Directive, including any reference to minimizing or reducing risk must be interpreted and applied in such a way as to take account of technology and practice existing at the time of design and of technical and economical considerations compatible with a high level of protection of health and safety;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, in accordance with the principles set out in the Council resolution of 7 May 1985 concerning a new approach to technical harmonization and standardization, rules regarding the design and manufacture of medical devices must be confined to the provisions required to meet the essential requirements; whereas, because they are essential, such requirements should replace the corresponding national provisions; 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; whereas the essential requirements should be applied with discretion to take account of the technological level existing at the time of design and of technical and economic considerations compatible with a high level of protection of health and safety;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;Whereas Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices is the first case of application of the new approach to the field of medical devices; whereas in the interest of uniform Community rules applicable to all medical devices, this Directive is based largely on the provisions of Directive 90/385/EEC; whereas for the same reasons Directive 90/385/EEC must be amended to insert the general provisions laid down in this Directive;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;Whereas the electromagnetic compatibility aspects form an integral part of the safety of medical devices; whereas this Directive should contain specific rules on this subject with regard to Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility; 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;Whereas this Directive should include requirements regarding the design and manufacture of devices emitting ionizing radiation; whereas this Directive does not affect the authorization required by Council Directive 80/836/Euratom of 15 July 1980 amending the Directives laying down the basic safety standards for the health protection of the general public and workers against the dangers of ionizing radiation, nor application of Council Directive 84/466/Euratom of 3 September 1984 laying down basic measures for the radiation protection of persons undergoing medical examination or treatment; whereas Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work and the specific directives on the same subject should continue to apply; 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, in order to demonstrate conformity with the essential requirements and to enable conformity to be verified, it is desirable to have harmonized European standards to protect against the risks associated with the design, manufacture and packaging of medical devices; whereas such harmonized European standards are drawn up by private-law bodies and should retain their status as non-mandatory texts; whereas, to this end, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are recognized as the competent bodies for the adoption of harmonized standards in accordance with the general guidelines on cooperation between the Commission and these two bodies signed on 13 November 1984;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(competent bodies),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, for the purpose of this Directive, a harmonized standard is a technical specification (European standard or harmonization document) adopted, on a mandate from the Commission, by either or both of these bodies in accordance with Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations, and pursuant to the abovementioned general guidelines; whereas with regard to possible amendment of the harmonized standards, the Commission should be assisted by the Committee set up pursuant to Directive 83/189/EEC; whereas the measures to be taken must be defined in line with procedure I, as laid down in Council Decision 87/373/EEC; whereas, for specific fields, what already exists in the form of European Pharmacopoeia monographs should be incorporated within the framework of this Directive; whereas, therefore, several European Pharmacopoeia monographs may be considered equal to the abovementioned harmonized standards;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 号指令程序一的规定; 鉴于特殊领域中现存的欧洲药典专题论文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, in Decision 90/683/EEC of 13 December 1990 concerning the modules for the various phases of the conformity assessment procedures which are intended to be used in the technical harmonization directives, the Council has laid down harmonized conformity assessment procedures; whereas the application of these modules to medical devices enables the responsibility of manufacturers and notified bodies to be determined during conformity assessment procedures on the basis of the type of devices concerned; whereas the details added to these modules are justified by the nature of the verification required for medical devices;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;Whereas it is necessary, essentially for the purpose of the conformity assessment procedures, to group the devices into four product classes; whereas the classification rules are based on the vulnerability of the human body taking account of the potential risks associated with the technical design and manufacture of the devices; whereas the conformity assessment procedures for Class I devices can be carried out, as a general rule, under the sole responsibility of the manufacturers in view of the low level of vulnerability associated with these products; whereas, for Class IIa devices, the intervention of a notified body should be compulsory at the production stage; whereas, for devices falling within Classes IIb and III which constitute a high risk potential, inspection by a notified body is required with regard to the design and manufacture of the devices; whereas Class III is set aside for the most critical devices for which explicit prior authorization with regard to conformity is required for them to be placed on the market;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;Whereas in cases where the conformity of the devices can be assessed under the responsibility of the manufacturer the competent authorities must be able, particularly in emergencies, to contact a person responsible for placing the device on the market and established in the Community, whether the manufacturer or another person established in the Community and designated by the manufacturer for the purpose;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;Whereas medical devices should, as a general rule, bear the CE mark to indicate their conformity with the provisions of this Directive to enable them to move freely within the Community and to be put into service in accordance with their intended purpose;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, in the fight against AIDS and in the light of the conclusions of the Council adopted on 16 May 1989 regarding future activities on AIDS prevention and control at Community level, medical devices used for protection against the HIV virus must afford a high level of protection; whereas the design and manufacture of such products should be verified by a notified body;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;Whereas the classification rules generally enable medical devices to be appropriately classified; whereas, in view of the diverse nature of the devices and technological progress in this field, steps must be taken to include amongst the implementing powers conferred on the Commission the decisions to be taken with regard to the proper classification or reclassification of the devices or, where appropriate, the adjustment of the classification rules themselves;whereas since these issues are closely connected with the protection of health, it is appropriate that these decisions should come under procedure IIIa, as provided for in Directive 87/373/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;Whereas the confirmation of complicance with the essential requirements may mean that clinical investigations have to be carried out under the responsibility of the manufacturer; whereas, for the purpose of carrying out the clinical investigations, appropriate means have to be specified for the protection of public health and public order;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;Whereas the protection of health and the associated controls may be made more effective by means of medical device vigilance systems which are integrated at Community level;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;Whereas this Directive covers the medical devices referred to in Council Directive 76/764/EEC of 27 July 1976 on the approximation of the laws of the Member States on clinical mercury-in-glass, maximum reading thermometers; whereas the abovementioned Directive must therefore be repealed; whereas for the same reasons Council Directive 84/539/EEC on 17 September 1984 on the approximation of the laws of the Member States relating to electro- medical equipment used in human or veterinary medicine must be amended,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,HAS ADOPTED THIS DlRECTIVE:爰制订本指令:Article 1第 1 条Definitions, scope定义, 范围1.This Directive shall apply to medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as medical devices in their own right. Both medical devices and accessories shall hereinafter be termed devices.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.For the purposes of this Directive, the following definitions shall apply: 为本指令的目地, 下列定义适用于:(a) M5 medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:医疗器械 是指制造商预定用于人体以下目的的任何仪器、装置、器具、材料或其他物品，无论它们是单独使用还是组合使用，包括製造商預定的用於人體診斷和/或治療目的的軟體及為其正常使用所需的軟體：-diagnosis, prevention, monitoring, treatment or alleviation of disease,诊断, 预防, 追踪, 治疗或减轻疾病,-diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,诊断, 追踪, 治疗或修整伤处或残障部位,-investigation, replacement or modification of the anatomy