{
  "url": "https://openlegislation.uk/eu-directive-1998-79/annex-V/division-2",
  "json_url": "https://openlegislation.uk/eu-directive-1998-79/annex-V/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/V/division/2",
  "kind": "division",
  "number": "2",
  "heading": null,
  "text": "The application for EC type-examination shall be lodged by the manufacturer or by his authorised representative with a notified body.\nThe application shall include:\nthe name and the address of the manufacturer and the name and address of the authorised representative if the application is lodged by the representative,\nthe documentation described in section 3 needed to assess the conformity of the representative sample of the production in question, hereinafter referred to as the ‘type’, with the requirements of this Directive. The applicant shall make a ‘type’ available to the notified body. The notified body may request other samples as necessary,\na written declaration that no application has been lodged with any other notified body for the same type.",
  "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/V/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."
}