{
  "url": "https://openlegislation.uk/eu-directive-1998-79/annex-I/division-B/division-7/division-7.1",
  "json_url": "https://openlegislation.uk/eu-directive-1998-79/annex-I/division-B/division-7/division-7.1.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/I/division/B/division/7/division/7.1",
  "kind": "division",
  "number": "7.1",
  "heading": null,
  "text": "Devices for self-testing must be designed and manufactured in such a way as to:\nensure that the device is easy to use by the intended lay user at all stages of the procedure, and\nreduce as far as practicable the risk of user error in the handling of the device and in the interpretation of the results.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/1998/79/annex/I/division/B/division/7/division/7.1",
    "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."
}