【2017年整理】93-42-EEC_完整版中英文对照.docVIP

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 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 the 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 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 prote