{
  "url": "https://openlegislation.uk/eu-directive-1998-79/annex-I/division-B/division-1/division-1.1",
  "json_url": "https://openlegislation.uk/eu-directive-1998-79/annex-I/division-B/division-1/division-1.1.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/1/division/1.1",
  "kind": "division",
  "number": "1.1",
  "heading": null,
  "text": "The devices must be designed and manufactured in such a way as to achieve the characteristics and performances referred to in section A on the ‘General requirements’. Particular attention must be paid to the possibility of impairment of analytical performance due to incompatibilitybetween the materials used and the specimens (such as biological tissues, cells, body fluids and micro-organisms) intended to be used with the device, taking account of its intended purpose.",
  "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/1/division/1.1",
    "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."
}