# 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

> The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released updated guidance concerning the in-house manufacture of medical devices in Great Britain, specifically focusing on the Health Institution Exemption (HIE). This document replaces outdated versions to provide a clearer regulatory framework for healthcare facilities that design and produce their own medical tools. While the text does not cite specific company violations or inspection dates, it addresses potential compliance issues by clarifying the scope of the HIE to prevent the improper use of the exemption. The guidance offers leading practice recommendations and scenario-based examples to assist institutions in correctly identifying when these rules apply. Required actions for health institutions include reviewing current manufacturing protocols to ensure they align with the clarified HIE scope and implementing the MHRA's best practices for safety and performance. By following this guidance, institutions can ensure that their internally produced devices meet high quality standards without needing the standard commercial markings, provided they remain within the defined legal boundaries for internal use only.

---

## 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)