{
  "url": "https://openlegislation.uk/eu-directive-1998-79/annex-IV/division-2",
  "json_url": "https://openlegislation.uk/eu-directive-1998-79/annex-IV/division-2.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/2",
  "kind": "division",
  "number": "2",
  "heading": null,
  "text": "The declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by section 1 ensures and declares that the devices concerned meet the provisions of this Directive which apply to them.\nThe manufacturer shall affix the CE marking in accordance with Article 16 and shall draw up a declaration of conformity covering the devices concerned.",
  "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/2",
    "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."
}