{
  "url": "https://openlegislation.uk/draft-human-medicines-and-medical-devices-amendment-etc-eu-exit-regulations-2019/schedule-2/paragraph-11",
  "json_url": "https://openlegislation.uk/draft-human-medicines-and-medical-devices-amendment-etc-eu-exit-regulations-2019/schedule-2/paragraph-11.json",
  "legislation": "ukdsi/2019/9780111189092",
  "legislation_title": "The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019",
  "legislation_url": "https://openlegislation.uk/draft-human-medicines-and-medical-devices-amendment-etc-eu-exit-regulations-2019",
  "path": "schedule/2/paragraph/11",
  "kind": "paragraph",
  "number": "11",
  "heading": "Amendment of regulation 12 (new Schedules to the 2002 Regulations)",
  "text": "(1) Regulation 12 is amended as follows.\n(2) In inserted Schedule 19 to the 2002 Regulations (technical documentation on post-market surveillance for in vitro diagnostic medical devices), in paragraph 5—\n(a) for “Article 81” substitute “regulation 189”;\n(b) for “Article 80” substitute “regulation 188”.\n(3) In inserted Schedule 24 to the 2002 Regulations (conformity assessment based on quality management system and on assessment of technical documentation - in vitro diagnostic medical devices), in paragraph 1(7)—\n(a) in the heading, omit “applicable to Class C and Class D devices”;\n(b) omit “of Class C and D devices”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2019/9780111189092/schedule/2/paragraph/11",
    "retrieved_at": "2026-10-30T14:59:28.001075+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."
}