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Commission Directive 2005/61/ECShow full title

Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events (Text with EEA relevance)

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Article 2Traceability

1.Member States shall ensure the traceability of blood and blood components through accurate identification procedures, record maintenance and an appropriate labelling system.

2.Member States shall ensure that the traceability system in place in the blood establishment enables the tracing of blood components to their location and processing stage.

3.Member States shall ensure that every blood establishment has a system in place to uniquely identify each donor, each blood unit collected and each blood component prepared, whatever its intended purpose, and the facilities to which a given blood component has been delivered.

4.Member States shall ensure that all facilities have a system in place to record each blood unit or blood component received, whether or not locally processed, and the final destination of that received unit, whether transfused, discarded or returned to the distributing blood establishment.

5.Member States shall ensure that every blood establishment has a unique identifier that enables it to be precisely linked to each unit of blood that it has collected and to each blood component that it has prepared.

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