{
  "url": "https://openlegislation.uk/medical-devices-amendment-eu-exit-regulations-2021/schedule-2/paragraph-7",
  "json_url": "https://openlegislation.uk/medical-devices-amendment-eu-exit-regulations-2021/schedule-2/paragraph-7.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/7",
  "kind": "paragraph",
  "number": "7",
  "heading": null,
  "text": "For Article 8 (which relates to review of obligations by a notified body) substitute—\n“Except for medical devices of Class I, as defined in Annex IX to Directive 93/42, the fulfilment of the obligations laid down in Articles 4 to 7 of this Regulation must be reviewed by an approved body during the applicable conformity assessment procedure for the medical device in question, as set out in Part 2 or Part 3 of the Medical Devices Regulations 2002. The review must be based on a specific sampling method adapted to the class and the complexity of the product.”.",
  "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/7",
    "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."
}