{
  "url": "https://openlegislation.uk/eu-decision-2002-364/annex/division-3/division-3.5/division-3.5.6",
  "json_url": "https://openlegislation.uk/eu-decision-2002-364/annex/division-3/division-3.5/division-3.5.6.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/3.5/division/3.5.6",
  "kind": "division",
  "number": "3.5.6",
  "heading": null,
  "text": "For devices intended for use with plasma the performance evaluation shall verify the performance of the device using all anticoagulants which the manufacturer indicates for use with the device. This shall be demonstrated for at least 50 donations.",
  "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/3.5/division/3.5.6",
    "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."
}