{
  "url": "https://openlegislation.uk/eu-directive-2006-86/annex-II/division-B",
  "json_url": "https://openlegislation.uk/eu-directive-2006-86/annex-II/division-B.json",
  "legislation": "eudr/2006/86",
  "legislation_title": "Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2006-86",
  "path": "annex/II/division/B",
  "kind": "division",
  "number": "B",
  "heading": "PROCESSING",
  "text": "When the activities for which the accreditation/designation/authorisation/licensing is sought include processing of tissues and cells, the tissue establishment procedures must comply with the following criteria:\n1.. The critical processing procedures must be validated and must not render the tissues or cells clinically ineffective or harmful to the recipient. This validation may be based on studies performed by the establishment itself, or on data from published studies or, for well established processing procedures, by retrospective evaluation of the clinical results for tissues supplied by the establishment.\n2.. It has to be demonstrated that the validated process can be carried out consistently and effectively in the tissue establishment environment by the staff.\n3.. The procedures must be documented in SOPs which must conform to the validated method and to the standards laid down in this Directive, accordingly with Annex I(E), points 1 to 4.\n4.. It must be ensured that all processes are conducted in accordance with the approved SOPs.\n5.. Where a microbial inactivation procedure is applied to the tissue or cells, it must be specified, documented, and validated.\n6.. Before implementing any significant change in processing, the modified process must be validated and documented.\n7.. The processing procedures must undergo regular critical evaluation to ensure that they continue to achieve the intended results.\n8.. Procedures for discarding tissue and cells must prevent the contamination of other donations and products, the processing environment or personnel. These procedures must comply with national regulations.",
  "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/2006/86/annex/II/division/B",
    "retrieved_at": "2026-11-01T15:22:33.600657+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."
}