{
  "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-44ZG",
  "json_url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-44ZG.json",
  "legislation": "uksi/2002/618",
  "legislation_title": "The Medical Devices Regulations 2002",
  "legislation_url": "https://openlegislation.uk/medical-devices-regulations-2002",
  "path": "regulation/44ZG",
  "kind": "regulation",
  "number": "44ZG",
  "heading": "Preventive and corrective actions",
  "text": "(1) If the manufacturer of a device—\n(a) identifies a risk that following evaluation is deemed to compromise the performance or safety of the device, or\n(b) otherwise has reason to believe that the device is not in conformity with the relevant essential requirements,\nthey must take the necessary preventive or corrective action as soon as possible to reduce that risk and bring the device into conformity.\n(2) The manufacturer must notify the action to—\n(a) the UK responsible person (if there is one);\n(b) the approved body for the device (if there is one);\n(c) if the action is a field safety corrective action, the Secretary of State in accordance with regulation 44ZJ (field safety corrective action).\n(3) The approved body must review the notification to determine whether there is any impact on the certification it has issued for the device.\n(4) The manufacturer must monitor the action to identify if any further action is required to reduce the risk posed and bring the device into conformity.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Pt. 4A inserted (E.W.S.) (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 4"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2002/618/regulation/44ZG",
    "retrieved_at": "2026-10-29T07:11:50.089580+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."
}