Consleg系统生产讲座(pdf 52页)
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资料简介：
COUNCIL DIRECTIVE 93/42/EEC
of 14 June 1993
concerning medical devices
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social
Committee (3),
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;
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;
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 market;
Whereas the harmonized provisions must be distinguished from the
measures adopted by the Member States to manage the funding of……
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