{
  "url": "https://openlegislation.uk/eu-directive-1998-79/annex-VII/division-1",
  "json_url": "https://openlegislation.uk/eu-directive-1998-79/annex-VII/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/VII/division/1",
  "kind": "division",
  "number": "1",
  "heading": null,
  "text": "The manufacturer must ensure application of the quality system approved for the manufacture of the devices concerned and carry out the final inspection, as specified in section 3, and is subject to the surveillance referred to in section 4.",
  "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/VII/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."
}