{
  "url": "https://openlegislation.uk/eu-directive-1998-79/annex-IV/division-3/division-3.1",
  "json_url": "https://openlegislation.uk/eu-directive-1998-79/annex-IV/division-3/division-3.1.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/3/division/3.1",
  "kind": "division",
  "number": "3.1",
  "heading": null,
  "text": "The manufacturer must lodge an application for assessment of his quality system with a notified body.\nThe application must include:\nthe name and address of the manufacturer and any additional manufacturing site covered by the quality system,\nadequate information on the device or device category covered by the procedure,\na written declaration that no such application has been lodged with any other notified body for the same device-related quality system,\nthe documentation on the quality system,\nan undertaking by the manufacturer to fulfil the obligations imposed by the quality system approved,\nan undertaking by the manufacturer to keep the approved quality system adequate and efficacious,\nan undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective action and notification as referred to in Annex III, section 5.",
  "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/3/division/3.1",
    "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."
}