{
  "url": "https://openlegislation.uk/eu-directive-1998-79/annex-I/division-B/division-4/division-4.1",
  "json_url": "https://openlegislation.uk/eu-directive-1998-79/annex-I/division-B/division-4/division-4.1.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/4/division/4.1",
  "kind": "division",
  "number": "4.1",
  "heading": null,
  "text": "Devices which are instruments or apparatus having a primary analytical measuring function must be designed and manufactured in such a way as to provide adequate stability and accuracy of measurement within appropriate accuracy limits, taking into account the intended purpose of the device and of available and appropriate reference measurement procedures and materials. The accuracy limits have to be specified by the manufacturer.",
  "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/4/division/4.1",
    "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."
}