{
  "url": "https://openlegislation.uk/eu-directive-2011-100/introduction",
  "json_url": "https://openlegislation.uk/eu-directive-2011-100/introduction.json",
  "legislation": "eudr/2011/100",
  "legislation_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)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2011-100",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Directive 2011/100/EU\nof 20 December 2011\namending Directive 98/79/EC of the European Parliament and of the Council on in-vitro diagnostic medical devices\n(Text with EEA relevance)\nTHE EUROPEAN COMMISSION,\nHaving regard to the Treaty on the Functioning of the European Union,\nHaving regard to Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in-vitro diagnostic medical devices, and in particular Article 14 thereof,\nWhereas:\n(1)\nIn accordance with Article 14(1)(a) of Directive 98/79/EC, the United Kingdom has requested that the Commission take the necessary measures to add ‘Variant Creutzfeldt-Jakob disease’ (vCJD) assays to List A of Annex II to that Directive.\n(2)\nIn order to ensure the highest level of health protection and ensure that the conformity of vCJD assays with the essential requirements set out in Annex I to Directive 98/79/EC is verified by notified bodies, vCJD assays for blood screening, diagnosis and confirmation should be added to List A of Annex II to Directive 98/79/EC.\n(3)\nThe measures provided for in this Directive are in accordance with the opinion of the Committee set up by Article 6(2) of Council Directive 90/385/EEC and referred to in Article 7(1) of Directive 98/79/EC,\nHAS ADOPTED THIS DIRECTIVE:",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ L 331, 7.12.1998, p. 1."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "OJ L 189, 20.7.1990, p. 17."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2011/100/introduction",
    "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."
}