# Health Institution Exemption for general medical devices

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/ed2e6f85-1162-45ba-a530-5474dd58a8b4
Type: Guidance
Published: December 17, 2025
Updated: January 20, 2026

> Guidance for health institutions that manufacture general medical devices under the Health Institution Exemption (HIE). 

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## Content

This guidance replaces the previous guidance on in-house manufacture of medical devices in Great Britain. It clarifies the current position on the scope of the Health Institution Exemption (HIE) and provides leading practice guidelines and scenario-based examples to illustrate how health institutions should apply the HIE.

## Attachments

- [Introduction](/government/publications/health-institution-exemption-for-general-medical-devices/introduction)
- [Leading practice guidelines](/government/publications/health-institution-exemption-for-general-medical-devices/leading-practice-guidelines)
- [Illustrative examples](/government/publications/health-institution-exemption-for-general-medical-devices/illustrative-examples)
- [General information on the Health Institution Exemption](/government/publications/health-institution-exemption-for-general-medical-devices/general-information-on-the-health-institution-exemption)