Introduction
Published 17 December 2025
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This publication is available at https://www.gov.uk/government/publications/health-institution-exemption-for-general-medical-devices/introduction
In alignment with the Government’s response to the 2021 consultation on the future regulation of medical devices, and in support of the 10 Year Health Plan for England as well as the Life Sciences Sector Plan, the MHRA is further developing its policy on the Health Institution Exemption (HIE). This evolving policy is designed to facilitate improved access to innovative medical technologies within local settings, whilst upholding robust safeguards for patients and protecting public health.
This guidance applies to health institutions in Great Britain (England, Wales, and Scotland). Health institutions in Northern Ireland can follow the relevant MDCG guidance, as outlined by published guidance in Information on the healthcare institution exemption applicable in Northern Ireland.
This guidance does not apply to in vitro diagnostic (IVD) devices. Health institutions who manufacture and use IVD devices can follow the IVD guidance in In vitro diagnostic medical devices: guidance on legislation.
In certain cases, health institutions may wish to consider an Exceptional Use Authorisation (EUA) to place medical devices on the market. An EUA exempts medical devices from certain parts of the Medical Devices Regulations 2002 (SI 2002 No. 618, as amended) (MDR 2002) when doing so is in the interest of the protection of public health. Manufacturers are subject to specific conditions and regulatory requirements to qualify for an EUA, refer to the EUA guidance for further details.