{
  "url": "https://openlegislation.uk/eu-directive-1990-385/annex-3/division-2",
  "json_url": "https://openlegislation.uk/eu-directive-1990-385/annex-3/division-2.json",
  "legislation": "eudr/1990/385",
  "legislation_title": "Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC)",
  "legislation_url": "https://openlegislation.uk/eu-directive-1990-385",
  "path": "annex/3/division/2",
  "kind": "division",
  "number": "2",
  "heading": null,
  "text": "The application for EC type-examination shall be made by the manufacturer, or by his authorized representative established in the Community, to a notified body.\nThe application shall include:\nthe name and address of the manufacturer and the name and address of the authorized representative if the application is made by the latter,\na written declaration specifying that an application has not been made to any other notified body,\nthe documentation described in section 3 needed to allow an evaluation to be made of the conformity of a representative sample of the production in question, hereinafter referred to as ‘type’, with the requirements of this Directive.\nThe applicant shall make a ‘type’ available to the notified body. The notified body may request other samples as necessary.",
  "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/1990/385/annex/3/division/2",
    "retrieved_at": "2026-11-01T15:23:27.423975+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."
}