{
  "url": "https://openlegislation.uk/eu-decision-2020-350/article-2",
  "json_url": "https://openlegislation.uk/eu-decision-2020-350/article-2.json",
  "legislation": "eudn/2020/350",
  "legislation_title": "Commission Implementing Decision (EU) 2020/350 of 28 February 2020 amending Decision 2002/364/EC as regards definitions of first–line assays and confirmatory assays, requirements for devices for self-testing and requirements for HIV and HCV rapid tests, confirmatory and supplementary assays (notified under document C(2020) 1086) (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2020-350",
  "path": "article/2",
  "kind": "article",
  "number": "2",
  "heading": null,
  "text": "1. This Decision shall apply from 2 March 2021.\n2. Notwithstanding paragraph 1, from 2 March 2020 until 1 July 2020 Member States shall apply the presumption of compliance laid down in Article 5(3) of Directive 98/79/EC for all in vitro diagnostic medical devices that comply with any of the following:\n(a) the common technical specifications laid down in Decision 2002/364/EC as amended by Commission Decision 2011/869/EU;\n(b) the common technical specifications laid down in Decision 2002/364/EC as amended by Commission Implementing Decision (EU) 2019/1244;\n(c) the common technical specifications laid down in Decision 2002/364/EC as amended by this Decision.\n3. Notwithstanding paragraph 1, from 2 July 2020 until 1 March 2021 Member States shall apply the presumption of compliance laid down in Article 5(3) of Directive 98/79/EC for all in vitro diagnostic medical devices that comply with either of the following:\n(a) the common technical specifications laid down in Decision 2002/364/EC as amended by Implementing Decision (EU) 2019/1244;\n(b) the common technical specifications laid down in 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)."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "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 (OJ L 193, 19.07.2019, p.1)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2020/350/article/2",
    "retrieved_at": "2026-11-01T15:12:22.094312+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."
}