# Custom-made medical devices in Great Britain

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/f502e7f2-6dea-49e0-b9c1-56a9a061f8d1
Type: Guidance
Published: August 15, 2013
Updated: June 16, 2025

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

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## Content

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.

## Attachments

- [Custom-made devices in Great Britain](/government/publications/custom-made-medical-devices/custom-made-devices-in-great-britain)
- [Examples of statements for custom-made medical devices](https://assets.publishing.service.gov.uk/media/5feb6247e90e0711fa94ce3b/Examples_of_custom_made_statements_Dec2020.pdf)