# 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), Article 1: Definitions

Extent: E+W+S+N.I.

For the purposes of this Directive, the following definitions shall apply:
(a) ‘traceability’ means the ability to trace each individual unit of blood or blood component derived thereof from the donor to its final destination, whether this is a recipient, a manufacturer of medicinal products or disposal, and vice versa;
(b) ‘reporting establishment’ means the blood establishment, the hospital blood bank or facilities where the transfusion takes place that reports serious adverse reactions and/or serious adverse events to the competent authority;
(c) ‘recipient’ means someone who has been transfused with blood or blood components;
(d) ‘issue’ means the provision of blood or blood components by a blood establishment or a hospital blood bank for transfusion to a recipient;
(e) ‘imputability’ means the likelihood that a serious adverse reaction in a recipient can be attributed to the blood or blood component transfused or that a serious adverse reaction in a donor can be attributed to the donation process;
(f) ‘facilities’ means hospitals, clinics, manufacturers, and bio-medical research institutions to which blood or blood components may be delivered.

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Source: https://www.legislation.gov.uk/eudr/2005/61/article/1 (the official version)
Page: https://openlegislation.uk/eu-directive-2005-61/article-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.