{
  "url": "https://openlegislation.uk/draft-medical-devices-amendment-etc-eu-exit-regulations-2020/schedule-1/paragraph-7",
  "json_url": "https://openlegislation.uk/draft-medical-devices-amendment-etc-eu-exit-regulations-2020/schedule-1/paragraph-7.json",
  "legislation": "ukdsi/2020/9780348214956",
  "legislation_title": "The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020",
  "legislation_url": "https://openlegislation.uk/draft-medical-devices-amendment-etc-eu-exit-regulations-2020",
  "path": "schedule/1/paragraph/7",
  "kind": "paragraph",
  "number": "7",
  "heading": "Insertion of regulation 19B",
  "text": "After regulation 19 insert—\n“Requirement to appoint a UK responsible person for general medical devices\n19B. (1) Paragraph (2) applies in relation to a manufacturer who—\n(a) does not have a registered place of business in the United Kingdom;\n(b) has not designated an authorised representative who has a registered place of business in Northern Ireland; and\n(c) places a relevant device, other than a Class I or custom-made device, on the market in Northern Ireland.\n(2) A manufacturer to whom this paragraph applies must appoint a person with a registered place of business in the United Kingdom as their UK responsible person to carry out the tasks described in regulations 19(2) and (5).”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2020/9780348214956/schedule/1/paragraph/7",
    "retrieved_at": "2026-10-30T14:48:13.546182+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."
}