{
  "url": "https://openlegislation.uk/eu-regulation-2013-920",
  "json_url": "https://openlegislation.uk/eu-regulation-2013-920.json",
  "id": "eur/2013/920",
  "title": "Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices (Text with EEA relevance)",
  "short_title": "Regulation (EU) No 920/2013 on the designation and the supervision of notified bodies under Council Directive…",
  "long_title": "Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices (Text with EEA relevance)",
  "citation": "EU Regulation No 920/2013",
  "type": "eur",
  "year": "2013",
  "number": "920",
  "version": "current",
  "date": "2013-09-24",
  "revised": false,
  "valid_from": null,
  "extent": "E+W+S+N.I.",
  "unapplied_effects": 1,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/eu-regulation-2013-920/introduction",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/1",
      "kind": "article",
      "number": "1",
      "heading": "Definitions",
      "url": "https://openlegislation.uk/eu-regulation-2013-920/article-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/1a",
      "kind": "article",
      "number": "1a",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2013-920/article-1a",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "article/2",
      "kind": "article",
      "number": "2",
      "heading": "Interpretation of designation criteria",
      "url": "https://openlegislation.uk/eu-regulation-2013-920/article-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/3",
      "kind": "article",
      "number": "3",
      "heading": "Procedure for the designation of approved bodies",
      "url": "https://openlegislation.uk/eu-regulation-2013-920/article-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/4",
      "kind": "article",
      "number": "4",
      "heading": "Extension and renewal of designation",
      "url": "https://openlegislation.uk/eu-regulation-2013-920/article-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/5",
      "kind": "article",
      "number": "5",
      "heading": "Surveillance and monitoring",
      "url": "https://openlegislation.uk/eu-regulation-2013-920/article-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/6",
      "kind": "article",
      "number": "6",
      "heading": "Investigation of the competence of an approved body",
      "url": "https://openlegislation.uk/eu-regulation-2013-920/article-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/7",
      "kind": "article",
      "number": "7",
      "heading": "Exchange of experience on designation and supervision of conformity assessment bodies",
      "url": "https://openlegislation.uk/eu-regulation-2013-920/article-7",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/8",
      "kind": "article",
      "number": "8",
      "heading": "Operating of designating authorities",
      "url": "https://openlegislation.uk/eu-regulation-2013-920/article-8",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/9",
      "kind": "article",
      "number": "9",
      "heading": "Cooperation with accreditation bodies",
      "url": "https://openlegislation.uk/eu-regulation-2013-920/article-9",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/10",
      "kind": "article",
      "number": "10",
      "heading": "Entry into force and date of application",
      "url": "https://openlegislation.uk/eu-regulation-2013-920/article-10",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "signature",
      "kind": "signature",
      "number": null,
      "heading": "Signature",
      "url": "https://openlegislation.uk/eu-regulation-2013-920/signature",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/I",
      "kind": "annex",
      "number": "I",
      "heading": "Interpretation of the criteria set out in Annex 8 to Directive 90/385/EEC and in Annex XI to Directive 93/42/EEC",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
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    },
    {
      "path": "annex/I/division/1",
      "kind": "division",
      "number": "1",
      "heading": "Sections 1 and 5 of Annex 8 to Directive 90/385/EEC and of Annex XI to Directive 93/42/EEC shall be interpreted as including the following elements:",
      "url": "https://openlegislation.uk/eu-regulation-2013-920/annex-I/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/2",
      "kind": "division",
      "number": "2",
      "heading": "The second paragraph of Section 2 of Annex XI to Directive 93/42/EEC shall be interpreted as including the following elements:",
      "url": "https://openlegislation.uk/eu-regulation-2013-920/annex-I/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/3",
      "kind": "division",
      "number": "3",
      "heading": "Sections 3 and 4 of Annex 8 to Directive 90/385/EEC and of Annex XI to Directive 93/42/EEC shall be interpreted as including the following elements:",
      "url": "https://openlegislation.uk/eu-regulation-2013-920/annex-I/division-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/4",
      "kind": "division",
      "number": "4",
      "heading": "Sections 6 of Annex 8 to Directive 90/385/EEC and of Annex XI to Directive 93/42/EEC shall be interpreted as including the following elements:",
      "url": "https://openlegislation.uk/eu-regulation-2013-920/annex-I/division-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/5",
      "kind": "division",
      "number": "5",
      "heading": "Sections 7 of Annex 8 to Directive 90/385/EEC and of Annex XI to Directive 93/42/EEC shall be interpreted as including the following elements:",
      "url": "https://openlegislation.uk/eu-regulation-2013-920/annex-I/division-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/II",
      "kind": "annex",
      "number": "II",
      "heading": "Application form to be submitted when applying for designation as an approved body",
      "url": "https://openlegislation.uk/eu-regulation-2013-920/annex-II",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    }
  ],
  "outstanding_effects": [],
  "made_under": [],
  "changes_made_to": 1,
  "changes_made_to_url": "https://openlegislation.uk/eu-regulation-2013-920/changes.json",
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  "instruments_made_under_url": "https://openlegislation.uk/eu-regulation-2013-920/instruments.json",
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2013/920",
    "retrieved_at": "2026-11-01T14:48:24.338131+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."
}