{
  "url": "https://openlegislation.uk/eu-directive-1993-42/annex-VI/division-5/division-5.1",
  "json_url": "https://openlegislation.uk/eu-directive-1993-42/annex-VI/division-5/division-5.1.json",
  "legislation": "eudr/1993/42",
  "legislation_title": "Council Directive 93/42/EEC of 14 June 1993 concerning medical devices",
  "legislation_url": "https://openlegislation.uk/eu-directive-1993-42",
  "path": "annex/VI/division/5/division/5.1",
  "kind": "division",
  "number": "5.1",
  "heading": null,
  "text": "The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, make available to the national authorities:\nthe declaration of conformity,\nthe documentation referred to in the seventh indent of Section 3.1,\nthe changes referred to in Section 3.4,\nthe decisions and reports from the notified body as referred to in the final indent of Section 3.4 and in Sections 4.3 and 4.4,\nwhere appropriate, the certificate of conformity referred to in Annex III.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Substituted by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/1993/42/annex/VI/division/5/division/5.1",
    "retrieved_at": "2026-11-01T15:23:18.816106+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."
}