体外诊断医疗器械指令98/97/EC

DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 1998 on in vitro diagnostic medical device

欧盟议会和委员会体外诊断医疗器械 98/97/EC指令（1998，10.27）

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 100a there of, 关于建立欧盟的协定和100a的特别协议

Having regard to the proposal from the Commission (1),关于委员会的建议（1） Having regard to the opinion of the Economic and Social Committee (2),

关于经济和社会委员会的观点（2）

Acting in accordance with the procedure laid down in Article 189b of the Treaty (3), 根据条约189b程序规定采取的方案(3) (1)Whereas measures should be adopted for the smooth operation 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;

…… 此处隐藏0字 ……

鉴于内部市场的顺利运作而采取的措施；鉴于欧盟内部市场是产品、人员、服务以及资本运作自由活动的无边界区域

(2)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 and authorisation procedures for in vitro diagnostic medical devices are different; whereas the existence of such disparities creates barriers to trade, and whereas the need to establish harmonised rules has been confirmed by a comparative survey of national legislations carried out on behalf of the Commission;

在体外诊断医疗器械反面欧盟成员国在安全、健康保障和能力、特点和授权程序方面的法律法规以及行政规定的范围和内容存在差异性；鉴于差异性的存在而产生贸易壁垒，同时需要建立代统一和谐规则，其规则是委员会授权调查立法部门根据其调查比较后确认的。

(3)Whereas the harmonisation of national legislation is the only means of removing such

barriers to free trade and of preventing new barriers from arising; whereas this objective cannot be achieved in a satisfactory manner by other means by the

individual Member States; whereas this Directive lays down only such requirements as are necessary and sufficient to ensure, under the best safety conditions, free movement of the in vitro diagnostic medical devices to which it applies。

立法意在消除自由贸易的壁垒同时防止其不再产生，其目标的达成没能取得令各成员都满意的方式，其指令仅仅规定了以最安全的方式采取与之相适应的必要而足够措施的体外医疗器械的自由贸易活动。