{
  "url": "https://openlegislation.uk/eu-directive-1998-79/annex-II",
  "json_url": "https://openlegislation.uk/eu-directive-1998-79/annex-II.json",
  "legislation": "eudr/1998/79",
  "legislation_title": "Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices",
  "legislation_url": "https://openlegislation.uk/eu-directive-1998-79",
  "path": "annex/II",
  "kind": "annex",
  "number": "II",
  "heading": "LIST OF DEVICES REFERRED TO IN ARTICLE 9(2) AND (3)",
  "text": "List A\nReagents and reagent products, including related calibrators and control materials, for determining the following blood groups: ABO system, rhesus (C, c, D, E, e) anti-Kell,\nreagents and reagent products, including related calibrators and control materials, for the detection, confirmation and quantification in human specimens of markers of HIV infection (HIV 1 and 2), HTLV I and II, and hepatitis B, C and D,\nvariant Creutzfeldt-Jakob disease (vCJD) assays for blood screening, diagnosis and confirmation.\nList B\nReagents and reagent products, including related calibrators and control materials, for determining the following blood groups: anti-Duffy and anti-Kidd,\nreagents and reagent products, including related calibrators and control materials, for determining irregular anti-erythrocytic antibodies,\nreagents and reagent products, including related calibrators and control materials, for the detection and quantification in human samples of the following congenital infections: rubella, toxoplasmosis,\nreagents and reagent products, including related calibrators and control materials, for diagnosing the following hereditary disease: phenylketonuria,\nreagents and reagent products, including related calibrators and control materials, for determining the following human infections: cytomegalovirus, chlamydia,\nreagents and reagent products, including related calibrators and control materials, for determining the following HLA tissue groups: DR, A, B,\nreagents and reagent products, including related calibrators and control materials, for determining the following tumoral marker: PSA,\nreagents and reagent products, including related calibrators, control materials and software, designed specifically for evaluating the risk of trisomy 21,\nthe following device for self-diagnosis, including its related calibrators and control materials: device for the measurement of blood sugar.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Substituted by Commission Directive 2011/100/EU of 20 December 2011 amending Directive 98/79/EC of the European Parliament and of the Council on in-vitro diagnostic medical devices (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Inserted by Commission Directive 2011/100/EU of 20 December 2011 amending Directive 98/79/EC of the European Parliament and of the Council on in-vitro diagnostic medical devices (Text with EEA relevance)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/1998/79/annex/II",
    "retrieved_at": "2026-11-01T15:23:06.143766+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."
}