{
  "url": "https://openlegislation.uk/medical-devices-amendment-eu-exit-regulations-2021/schedule-2/paragraph-26",
  "json_url": "https://openlegislation.uk/medical-devices-amendment-eu-exit-regulations-2021/schedule-2/paragraph-26.json",
  "legislation": "uksi/2021/873",
  "legislation_title": "The Medical Devices (Amendment) (EU Exit) Regulations 2021",
  "legislation_url": "https://openlegislation.uk/medical-devices-amendment-eu-exit-regulations-2021",
  "path": "schedule/2/paragraph/26",
  "kind": "paragraph",
  "number": "26",
  "heading": null,
  "text": "In Article 5 (surveillance and monitoring)—\n(a) in paragraph 1—\n(i) for “notified” in each place it occurs, substitute “approved”,\n(ii) in the first sub-paragraph, for “designating authority of the Member State where the notified body is established” substitute “Secretary of State”,\n(iii) in the third sub-paragraph, for “That designating authority” substitute “The Secretary of State”;\n(b) in paragraph 2, for “designating authorities”, substitute “Secretary of State”;\n(c) in paragraph 3—\n(i) for the first sub-paragraph substitute—\n“The Secretary of State shall continuously monitor that body to ensure ongoing compliance with the applicable requirements. The Secretary of State shall provide for a systematic follow-up of complaints, vigilance reports and other information, including from outside the United Kingdom, which might indicate the non-fulfilment of the obligations by an approved body or its deviation from common or best practice.”,\n(ii) in the second sub-paragraph, for “designating authority of the Member State where the notified body is established” substitute “Secretary of State”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2021/873/schedule/2/paragraph/26",
    "retrieved_at": "2026-10-28T22:10:33.646062+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."
}