{
  "url": "https://openlegislation.uk/eu-regulation-2013-920/annex-I/division-5",
  "json_url": "https://openlegislation.uk/eu-regulation-2013-920/annex-I/division-5.json",
  "legislation": "eur/2013/920",
  "legislation_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)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2013-920",
  "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:",
  "text": "5.1.The conformity assessment body shall ensure that confidentiality of the information which comes into its possession during the performance of the conformity assessment activities is observed by its personnel, committees, subsidiaries, subcontractors or any associated body, except when disclosure is required by law. To this end, it shall have documented procedures in place.\n5.2.The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks, except in relation to the designating authorities and the competent authorities or the Commission. Proprietary rights shall be protected. To this end, the conformity assessment body shall have documented procedures in place.",
  "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/eur/2013/920/annex/I/division/5",
    "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."
}