{
  "url": "https://openlegislation.uk/eu-directive-1998-79/annex-V/division-5",
  "json_url": "https://openlegislation.uk/eu-directive-1998-79/annex-V/division-5.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/5",
  "kind": "division",
  "number": "5",
  "heading": null,
  "text": "If the type conforms to the provisions of this Directive, the notified body shall issue the applicant with an EC type-examination certificate. The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions of validity and the data needed for identification of the type approved. The relevant parts of the documentation shall be annexed to the certificate and a copy shall be kept by the notified body.",
  "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/5",
    "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."
}