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: 15 January 2025 — See all updates

Documents

Custom-made devices in Great Britain

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

Published 16 August 2013
Last updated 15 January 2025 + show all updates

1. 15 January 2025

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

2. 31 December 2020

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

3. 16 August 2013

   First published.