{
  "url": "https://openlegislation.uk/eu-decision-2009-886/introduction",
  "json_url": "https://openlegislation.uk/eu-decision-2009-886/introduction.json",
  "legislation": "eudn/2009/886",
  "legislation_title": "Commission Decision of 27 November 2009 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (notified under document C(2009) 9464) (Text with EEA relevance) (2009/886/EC)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2009-886",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Decision\nof 27 November 2009\namending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices\n(notified under document C(2009) 9464)\n(Text with EEA relevance)\n(2009/886/EC)\nTHE COMMISSION OF THE EUROPEAN COMMUNITIES,\nHaving regard to the Treaty establishing the European Community,\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 and in order to reflect technical progress including the evolution in the performance and analytical sensitivity of devices, it is appropriate to revise the common technical specifications laid down in Decision 2002/364/EC.\n(3)\nThe definition of rapid test should be refined in order for it to be more precise. For the sake of clarity further definitions should be included.\n(4)\nTo bring the common technical specifications in line with current scientific and technical practices it is necessary to update a number of scientific and technical references.\n(5)\nThe requirements for HIV screening assays should be clarified. In order to ensure that the performance criteria appropriate to today’s technology is reflected in the common technical specifications it is necessary to add requirements for HIV antibody/antigen combined tests and further specification of the sample requirements for certain assays.\n(6)\nThe Annex to Decision 2002/364/EC should therefore be amended accordingly and, for the purpose of clarity, be replaced.\n(7)\nDue to an administrative error, Commission Decision 2009/108/EC of 3 February 2009 amending Decision 2002/364/EC on common technical specifications for in vitro-diagnostic medical devices was adopted without the European Parliament being given the possibility to exercise its right of scrutiny in accordance with Article 8 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission. Therefore, Decision 2009/108/EC should be replaced by this Decision.\n(8)\nManufacturers whose devices are already on the market should be given a transitional period in order to adapt to the new common technical specifications. On the other hand, in the interest of public health, manufacturers who so wish should be able to apply the new common technical specifications before the expiry of the transitional period.\n(9)\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,\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": "OJ L 39, 10.2.2009, p. 34."
    },
    {
      "type": "footnote",
      "label": "f4",
      "text": "OJ L 184, 17.7.1999, p. 23."
    },
    {
      "type": "footnote",
      "label": "f5",
      "text": "OJ L 189, 20.7.1990, p. 17."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2009/886/introduction",
    "retrieved_at": "2026-11-01T15:16:19.514972+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."
}