{
  "url": "https://openlegislation.uk/eu-decision-2019-1244/article-2",
  "json_url": "https://openlegislation.uk/eu-decision-2019-1244/article-2.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": "article/2",
  "kind": "article",
  "number": "2",
  "heading": null,
  "text": "This Decision shall apply from 2 July 2020.\nUntil that date, Member States shall apply the presumption of compliance referred to in Article 5(3) of Directive 98/79/EC for all in vitro diagnostic medical devices that comply with either of the following specifications:\n(a) the common technical specifications laid down in the Annex to Decision 2002/364/EC as amended by Commission Decision 2011/869/EU;\n(b) the common technical specifications laid down in the Annex to Decision 2002/364/EC as amended by this Decision.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Commission Decision 2011/869/EU of 20 December 2011 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (OJ L 341, 22.12.2011, p. 63)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2019/1244/article/2",
    "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."
}