{
  "url": "https://openlegislation.uk/eu-decision-2019-1244/introduction",
  "json_url": "https://openlegislation.uk/eu-decision-2019-1244/introduction.json",
  "legislation": "eudn/2019/1244",
  "legislation_title": "Commission Implementing Decision (EU) 2019/1244 of 1 July 2019 amending Decision 2002/364/EC as regards requirements for HIV and HCV antigen and antibody combined tests and as regards requirements for nucleic acid amplification techniques with respect to reference materials and qualitative HIV assays (notified under document C(2019) 4632) (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2019-1244",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Implementing Decision (EU) 2019/1244\nof 1 July 2019\namending Decision 2002/364/EC as regards requirements for HIV and HCV antigen and antibody combined tests and as regards requirements for nucleic acid amplification techniques with respect to reference materials and qualitative HIV assays\n(notified under document C(2019) 4632)\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 the second subparagraph of Article 5(3) thereof,\nWhereas:\n(1)\nPursuant to Article 5(3) of Directive 98/79/EC, Member States are to presume compliance with the essential requirements referred to in Article 3 of that Directive in respect of devices designed and manufactured in conformity with common technical specifications. The 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 patient safety and in order to reflect scientific and technological progress, including the evolution in the intended use, performance and analytical sensitivity of certain devices, it is appropriate to further revise the common technical specifications laid down in Decision 2002/364/EC.\n(3)\nTaking into account the evolving state of the art, changing clinical needs, growing scientific knowledge, and the new types of devices present on the market, the common technical specifications should be amended with respect to the requirements for HIV and hepatitis C virus (HCV) antigen and antibody combined tests, as well as the requirements for nucleic acid amplification techniques as regards reference materials and qualitative HIV assays.\n(4)\nThe manufacturers should be allowed time to adapt to the new common technical specifications. The date of application of the requirements laid down in this Decision should therefore be deferred. However, in the interest of public health and patient safety, manufacturers should be allowed to follow the new common technical specifications before the date of application on a voluntary basis.\n(5)\nThe measures provided for in this Decision are in accordance with the opinion of the Committee established 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": "Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (OJ L 131, 16.5.2002, p. 17)."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2019/1244/introduction",
    "retrieved_at": "2026-11-01T15:12:37.967137+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."
}