{
  "url": "https://openlegislation.uk/eu-directive-2005-61/article-1",
  "json_url": "https://openlegislation.uk/eu-directive-2005-61/article-1.json",
  "legislation": "eudr/2005/61",
  "legislation_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)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2005-61",
  "path": "article/1",
  "kind": "article",
  "number": "1",
  "heading": "Definitions",
  "text": "For the purposes of this Directive, the following definitions shall apply:\n(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;\n(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;\n(c) ‘recipient’ means someone who has been transfused with blood or blood components;\n(d) ‘issue’ means the provision of blood or blood components by a blood establishment or a hospital blood bank for transfusion to a recipient;\n(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;\n(f) ‘facilities’ means hospitals, clinics, manufacturers, and bio-medical research institutions to which blood or blood components may be delivered.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2005/61/article/1",
    "retrieved_at": "2026-11-01T15:22:40.913360+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}