{
  "url": "https://openlegislation.uk/medical-devices-northern-ireland-protocol-regulations-2021/regulation-11",
  "json_url": "https://openlegislation.uk/medical-devices-northern-ireland-protocol-regulations-2021/regulation-11.json",
  "legislation": "uksi/2021/905",
  "legislation_title": "The Medical Devices (Northern Ireland Protocol) Regulations 2021",
  "legislation_url": "https://openlegislation.uk/medical-devices-northern-ireland-protocol-regulations-2021",
  "path": "regulation/11",
  "kind": "regulation",
  "number": "11",
  "heading": "Ethical review of clinical investigations",
  "text": "(1) A sponsor proposing to conduct a clinical investigation of a device in Northern Ireland must apply to an ethics committee for an ethical review of the proposed clinical investigation.\n(2) The sponsor must submit to the Secretary of State a copy of the opinion of the ethics committee as soon as it becomes available and before the clinical investigation is started.",
  "extent": "N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 11 in force at 27.7.2021, see reg. 1(2)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2021/905/regulation/11",
    "retrieved_at": "2026-10-28T22:10:11.075057+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."
}