Directive 2001/104/EC of the European Parliament and of the Council of 7 December 2001 amending Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance)

Directive 2001/104/EC of the European Parliament and of the Council
of 7 December 2001
amending Council Directive 93/42/EEC concerning medical devices
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION
,
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the Economic and Social Committee,
Acting in accordance with the procedure laid down in Article 251 of the Treaty(1),
Whereas:
(1) This Directive aims at including in the scope of Directive 93/42/EEC(2) only medical devices which incorporate, as an integral part, substances derived from human blood or human plasma. Medical devices incorporating other substances derived from human tissues remain excluded from the scope of the said Directive.
(2) The essential aim of any rules governing the production, distribution or use of medical devices must be to safeguard public health.
(3) 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 harmonised in order to guarantee free movement of such devices within the internal market,