Guidance

Custom-made medical devices in Great Britain

How to comply with the regulatory requirements for manufacturing custom-made medical devices.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 16 August 2013
• Last updated: 20 July 2026
  Show all updates

  1. 20 July 2026

     Updated to clarify registration requirements for custom-made devices

  2. 16 June 2025

     Updated to reflect the coming into force of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.

  3. 15 January 2025

     Updated to reflect the laying of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.

  4. 31 December 2020

     This has been updated due to the end of the Brexit transition period.

  5. 16 August 2013

     First published.

Documents

Custom-made devices in Great Britain

HTML

Examples of statements for custom-made medical devices

PDF, 268 KB, 7 pages

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Details

Guidance for manufacturers on how to comply with the legal requirements for custom-made active implantable medical devices and custom-made medical devices.

This information also explains what a custom-made device is and gives examples.