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

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 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 t