{
  "url": "https://openlegislation.uk/eu-directive-2003-32",
  "json_url": "https://openlegislation.uk/eu-directive-2003-32.json",
  "id": "eudr/2003/32",
  "title": "Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (Text with EEA relevance) (repealed)",
  "short_title": "Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin",
  "long_title": "Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (Text with EEA relevance) (repealed)",
  "citation": "EU Directive 2003/32",
  "type": "eudr",
  "year": "2003",
  "number": "32",
  "version": "current",
  "date": "2003-04-23",
  "revised": false,
  "valid_from": null,
  "extent": "E+W+S+N.I.",
  "unapplied_effects": 0,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/eu-directive-2003-32/introduction",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/1",
      "kind": "article",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2003-32/article-1",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/2",
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      "status": "repealed",
      "parent": null
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    {
      "path": "article/3",
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      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/4",
      "kind": "article",
      "number": "4",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2003-32/article-4",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/5",
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      "number": "5",
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      "url": "https://openlegislation.uk/eu-directive-2003-32/article-5",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/6",
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      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2003-32/article-6",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/7",
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      "parent": null
    },
    {
      "path": "article/8",
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      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/9",
      "kind": "article",
      "number": "9",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2003-32/article-9",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/10",
      "kind": "article",
      "number": "10",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2003-32/article-10",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "annex",
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      "number": null,
      "heading": null,
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "annex/division/1",
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      "number": "1",
      "heading": "RISK ANALYSIS AND RISK MANAGEMENT",
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    {
      "path": "annex/division/1/division/1.1",
      "kind": "division",
      "number": "1.1",
      "heading": "Justification for the use of animal tissues or derivatives",
      "url": "https://openlegislation.uk/eu-directive-2003-32/annex/division-1/division-1.1",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex/division/1"
    },
    {
      "path": "annex/division/1/division/1.2",
      "kind": "division",
      "number": "1.2",
      "heading": "Assessment procedure",
      "url": "https://openlegislation.uk/eu-directive-2003-32/annex/division-1/division-1.2",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex/division/1"
    },
    {
      "path": "annex/division/1/division/1.2/division/1.2.1",
      "kind": "division",
      "number": "1.2.1",
      "heading": "Animals as a source of material",
      "url": "https://openlegislation.uk/eu-directive-2003-32/annex/division-1/division-1.2/division-1.2.1",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex/division/1/division/1.2"
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      "path": "annex/division/1/division/1.2/division/1.2.2",
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      "url": "https://openlegislation.uk/eu-directive-2003-32/annex/division-1/division-1.2/division-1.2.2",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex/division/1/division/1.2"
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      "path": "annex/division/1/division/1.2/division/1.2.3",
      "kind": "division",
      "number": "1.2.3",
      "heading": "Nature of starting tissue",
      "url": "https://openlegislation.uk/eu-directive-2003-32/annex/division-1/division-1.2/division-1.2.3",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex/division/1/division/1.2"
    },
    {
      "path": "annex/division/1/division/1.2/division/1.2.3/division/1.2.3.1",
      "kind": "division",
      "number": "1.2.3.1",
      "heading": "Sheep and goats",
      "url": "https://openlegislation.uk/eu-directive-2003-32/annex/division-1/division-1.2/division-1.2.3/division-1.2.3.1",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex/division/1/division/1.2/division/1.2.3"
    },
    {
      "path": "annex/division/1/division/1.2/division/1.2.3/division/1.2.3.2",
      "kind": "division",
      "number": "1.2.3.2",
      "heading": "Cattle",
      "url": "https://openlegislation.uk/eu-directive-2003-32/annex/division-1/division-1.2/division-1.2.3/division-1.2.3.2",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex/division/1/division/1.2/division/1.2.3"
    },
    {
      "path": "annex/division/1/division/1.2/division/1.2.4",
      "kind": "division",
      "number": "1.2.4",
      "heading": "Inactivation or removal of transmissible agents",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex/division/1/division/1.2"
    },
    {
      "path": "annex/division/1/division/1.2/division/1.2.4/division/1.2.4.1",
      "kind": "division",
      "number": "1.2.4.1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2003-32/annex/division-1/division-1.2/division-1.2.4/division-1.2.4.1",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex/division/1/division/1.2/division/1.2.4"
    },
    {
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    },
    {
      "path": "annex/division/1/division/1.2/division/1.2.5",
      "kind": "division",
      "number": "1.2.5",
      "heading": "Quantities of animal starting tissues or derivatives required to produce one unit of the medical device",
      "url": "https://openlegislation.uk/eu-directive-2003-32/annex/division-1/division-1.2/division-1.2.5",
      "extent": "E+W+S+N.I.",
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      "parent": "annex/division/1/division/1.2"
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      "heading": "Tissues or derivatives of animal origin coming into contact with the patients and users",
      "url": "https://openlegislation.uk/eu-directive-2003-32/annex/division-1/division-1.2/division-1.2.6",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex/division/1/division/1.2"
    },
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      "extent": "E+W+S+N.I.",
      "status": "repealed",
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      "heading": "EVALUATION OF CLASS III MEDICAL DEVICES BY NOTIFIED BODIES",
      "url": "https://openlegislation.uk/eu-directive-2003-32/annex/division-2",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex"
    }
  ],
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  "provenance": {
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    "source_url": "https://www.legislation.gov.uk/eudr/2003/32",
    "retrieved_at": "2026-11-01T15:22:54.473300+00:00"
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  "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."
}