{
  "url": "https://openlegislation.uk/eu-decision-2002-364/annex/division-3/division-3.1/division-1/division-3.1.14",
  "json_url": "https://openlegislation.uk/eu-decision-2002-364/annex/division-3/division-3.1/division-1/division-3.1.14.json",
  "legislation": "eudn/2002/364",
  "legislation_title": "Commission Decision of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (notified under document number C(2002) 1344) (Text with EEA relevance) (2002/364/EC)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2002-364",
  "path": "annex/division/3/division/3.1/division/1/division/3.1.14",
  "kind": "division",
  "number": "3.1.14",
  "heading": null,
  "text": "For devices intended by the manufacturer to be used with serum and plasma the performance evaluation must demonstrate serum to plasma equivalency. This shall be demonstrated for at least 50 donations (25 positive and 25 negative).",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Substituted by 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)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2002/364/annex/division/3/division/3.1/division/1/division/3.1.14",
    "retrieved_at": "2026-11-01T15:18:33.780237+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."
}