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
• Last updated: 20 January 2026
  Show all updates

  1. 20 January 2026

     Removed the sentence: " the MHRA will not consider this as an enforcement priority currently, provided the leading practice guidelines are followed" from General Information on Health Institution's premises.

  2. 17 December 2025

     First published.

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.