{
  "url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-44ZQ",
  "json_url": "https://openlegislation.uk/medical-devices-regulations-2002/regulation-44ZQ.json",
  "legislation": "uksi/2002/618",
  "legislation_title": "The Medical Devices Regulations 2002",
  "legislation_url": "https://openlegislation.uk/medical-devices-regulations-2002",
  "path": "regulation/44ZQ",
  "kind": "regulation",
  "number": "44ZQ",
  "heading": "Retention of post-market surveillance documentation",
  "text": "(1) The manufacturer and the UK responsible person (if there is one) must retain the documentation drawn up for the purposes of this Part for the period set out in paragraph (2).\n(2) The period is the longer of—\n(a) the PMS period for the device model, and\n(b) 15 years in the case of an implantable device, or 10 years in the case of any other device.",
  "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/44ZQ",
    "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."
}