Considerations on COM(2001)480 - Amendment of Council Directive 93/42/EEC, as amended by Directive 2000/70/EC, as regards medical devices incorporating stable derivates of human blood or human plasma

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(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.