{
  "url": "https://openlegislation.uk/eu-directive-2011-100",
  "json_url": "https://openlegislation.uk/eu-directive-2011-100.json",
  "id": "eudr/2011/100",
  "title": "Commission Directive 2011/100/EU of 20 December 2011 amending Directive 98/79/EC of the European Parliament and of the Council on in-vitro diagnostic medical devices (Text with EEA relevance)",
  "short_title": "Commission Directive 2011/100/EU of 20 December 2011 amending Directive 98/79/EC of the European Parliament and of the Council on in-vitro diagnostic medical devices",
  "long_title": "Commission Directive 2011/100/EU of 20 December 2011 amending Directive 98/79/EC of the European Parliament and of the Council on in-vitro diagnostic medical devices (Text with EEA relevance)",
  "citation": "EU Directive 2011/100",
  "type": "eudr",
  "year": "2011",
  "number": "100",
  "version": "current",
  "date": "2011-12-20",
  "revised": false,
  "valid_from": null,
  "extent": "E+W+S+N.I.",
  "unapplied_effects": 1,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/eu-directive-2011-100/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-2011-100/article-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/2",
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      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2011-100/article-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/3",
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      "number": "3",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2011-100/article-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/4",
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      "number": "4",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2011-100/article-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "signature",
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      "heading": "Signature",
      "url": "https://openlegislation.uk/eu-directive-2011-100/signature",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex",
      "kind": "annex",
      "number": null,
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2011-100/annex",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    }
  ],
  "outstanding_effects": [
    {
      "type": "implicit repeal",
      "affected_provisions": "Directive",
      "affecting": "eur/2017/746",
      "affecting_title": "Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. )",
      "affecting_provisions": "Regulation"
    }
  ],
  "made_under": [],
  "changes_made_to": 1,
  "changes_made_to_url": "https://openlegislation.uk/eu-directive-2011-100/changes.json",
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  "instruments_made_under": 0,
  "instruments_made_under_url": "https://openlegislation.uk/eu-directive-2011-100/instruments.json",
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2011/100",
    "retrieved_at": "2026-11-01T15:21:57.831246+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."
}