{
  "url": "https://openlegislation.uk/eu-directive-2005-62/annex/division-4/division-3",
  "json_url": "https://openlegislation.uk/eu-directive-2005-62/annex/division-4/division-3.json",
  "legislation": "eudr/2005/62",
  "legislation_title": "Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2005-62",
  "path": "annex/division/4/division/3",
  "kind": "division",
  "number": "3",
  "heading": null,
  "text": "Only reagents and materials from approved suppliers that meet the documented requirements and specifications shall be used. Critical materials shall be released by a person qualified to perform this task. Where relevant, materials, reagents and equipment shall meet the requirements of Council Directive 93/42/EEC for medical devices and Directive 98/79/EC of the European Parliament and of the Council for in vitro diagnostic medical devices or comply with equivalent standards in the case of collection in third countries.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ L 169, 12.7.1993, p. 1. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1)."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "OJ L 331, 7.12.1998, p. 1. Directive as amended by Regulation (EC) No 1882/2003."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2005/62/annex/division/4/division/3",
    "retrieved_at": "2026-11-01T15:22:40.840805+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."
}