{
  "url": "https://openlegislation.uk/eu-directive-1998-79/annex-IV/division-1",
  "json_url": "https://openlegislation.uk/eu-directive-1998-79/annex-IV/division-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/IV/division/1",
  "kind": "division",
  "number": "1",
  "heading": null,
  "text": "The manufacturer must ensure application of the quality system approved for the design, manufacture and final inspection of the devices concerned, as specified in section 3, and is subject to audit as laid down in section 3.3 and to the surveillance as specified in section 5. In addition, the manufacturer must follow, for devices covered by Annex II, List A, the procedures laid down in sections 4 and 6.",
  "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/IV/division/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."
}