Guidance

Health Institution Exemption for general medical devices

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

• From: Medicines and Healthcare products Regulatory Agency
• Published: 17 December 2025

Documents

Introduction

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General information on the Health Institution Exemption

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Leading practice guidelines

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Illustrative examples

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Details

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.

Published 17 December 2025