preamble_28

Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC · European Union

(17) An adequate system to ensure traceability of whole blood and blood components should be established. Traceability should be enforced through accurate donor, patient, and laboratory identification procedures, through record maintenance, and through an appropriate identification and labelling system. It is desirable that a system is developed in order to enable the unique and unmistakable identification of donations of blood and blood components in the Community. In the case of blood and blood components imported from third countries, it is important that an equivalent level of traceability be ensured by the blood establishments in the stages preceding importation into the Community. The same requirements of traceability which apply to blood and blood components collected in the Community should be ensured in the stages following importation.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-05 · Text as adopted (Official Journal); later amendments are not incorporated in this text.