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1、 COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 1993 年 6 月 14 日理事会第 93/42/EEC 号指令 concerning medical devices 关于医疗器械 更改历史记录： ? M1 Directive 98/79/EC of the European Parliament and of the Council of L 331 1 7.12.1998 27 October 1998 ? M2 Directive 2000/70/EC of the European Parliament and of the Council
2、of L 313 22 13.12.2000 16 November 2000 ? M3 Directive 2001/104/EC of the European Parliament and of the Council L 6 50 10.1.2002 of 7 December 2001 ? M4 Regulation (EC) No 1882/2003 of the European Parliament and of the L 284 1 31.10.2003 Council of 29 September 2003 ? M5 Directive 2007/47/EC of th
3、e European Parliament and of the Council of L 247 21 21.9.2007 5 September 2007 THE 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 prop
4、osal 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 fro
5、ntiers 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 prot
6、ection 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
7、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 d
8、evices 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 ind
9、irectly 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; Wherea
10、s 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 improvement of the level of protection attained in the Member States is one of the essen
11、tial 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 Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid dow
12、n 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/
13、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/
14、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 incorp
15、orated 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 appro
16、priate 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
