{
  "url": "https://openlegislation.uk/eu-decision-2011-869/introduction",
  "json_url": "https://openlegislation.uk/eu-decision-2011-869/introduction.json",
  "legislation": "eudn/2011/869",
  "legislation_title": "Commission Decision of 20 December 2011 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (notified under document C(2011) 9398) (Text with EEA relevance) (2011/869/EU)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2011-869",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Decision\nof 20 December 2011\namending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices\n(notified under document C(2011) 9398)\n(Text with EEA relevance)\n(2011/869/EU)\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 the second subparagraph of Article 5(3) thereof,\nWhereas:\n(1)\nThe common technical specifications for in vitro diagnostic medical devices are laid down in Commission Decision 2002/364/EC.\n(2)\nIn the interest of public health it is appropriate, where possible, to draw up common technical specifications for the devices listed in List A of Annex II to Directive 98/79/EC.\n(3)\nVariant Creutzfeldt-Jakob disease (vCJD) assays for blood screening, diagnosis and confirmation have been added to List A of Annex II to Directive 98/79/EC by Commission Directive 2011/100/EU.\n(4)\nTaking into account the state of the art and the current scientific knowledge on Variant Creutzfeldt-Jakob disease, common technical specifications can be drawn up for vCJD blood screening assays.\n(5)\nThe measures provided for in this Decision 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 DECISION:",
  "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 131, 16.5.2002, p. 17."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "See page 50 of this Official Journal."
    },
    {
      "type": "footnote",
      "label": "f4",
      "text": "OJ L 189, 20.7.1990, p. 17."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2011/869/introduction",
    "retrieved_at": "2026-11-01T15:15:35.673908+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."
}