{
  "url": "https://openlegislation.uk/medical-devices-amendment-regulations-2008/regulation-6",
  "json_url": "https://openlegislation.uk/medical-devices-amendment-regulations-2008/regulation-6.json",
  "legislation": "uksi/2008/2936",
  "legislation_title": "The Medical Devices (Amendment) Regulations 2008",
  "legislation_url": "https://openlegislation.uk/medical-devices-amendment-regulations-2008",
  "path": "regulation/6",
  "kind": "regulation",
  "number": "6",
  "heading": "Amendment of regulation 9 of the principal Regulations",
  "text": "In regulation 9 of the principal Regulations (determining compliance of general medical devices with relevant essential requirements)—\n(a) after paragraph (5), insert—\n“(5A) When a custom-made device is supplied to a patient, the healthcare professional who writes the prescription for the custom-made device shall, in relation to each patient that they supply with such a device—\n(a) ensure that the patient is aware that they may request the statement containing the information required by Sections 1 and 2 of Annex VIII; and\n(b) ensure that the statement containing the information required by Sections 1 and 2 of Annex VIII is made available to the patient on request.”; and\n(b) after sub-paragraph (8) insert—\n“(9) Where a device is intended by the manufacturer to be used in conjunction with both the provisions in Council Directive 89/686/EEC on the approximation or the laws of the Member States relating to personal protective equipment and Directive 93/42, the relevant basic health and safety requirements of Directive 89/686/EEC shall also be fulfilled.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ No. L 399, 30.12.1989, p.18; as last amended by Regulation (EC) No. 1882/2003 (OJ No. L 284, 31.10.2003, p.1)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2008/2936/regulation/6",
    "retrieved_at": "2026-10-29T03:22:08.877648+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."
}