Health Institution Exemption for General Medical Devices

18th December 2025

Health Institution Exemption for General Medical Devices

Summary: The Health Institution Exemption (HIE) allows certain medical devices to be manufactured and used in-house by health institutions in Great Britain without a full UKCA conformity assessment, provided specific conditions are met. This guidance clarifies eligibility, responsibilities and compliance expectations for hospitals, clinics and other health institutions using the exemption. Key points include:

• Scope of HIE: The exemption applies to devices manufactured and used within the same health institution (e.g., NHS trusts, hospitals) and not placed on the wider market. It covers devices that meet the definition of a medical device under UK law but are intended solely for use within the institution.

• Requirements: Institutions must document rationale for using the exemption, ensure devices are suitable and safe for intended purposes, and maintain robust quality and safety systems (including risk management, performance verification, labelling and record-keeping).

• Conditions: Exempt devices must not be distributed or transferred outside the institution, and institutions must be able to demonstrate compliance during inspections. They must also meet applicable labelling and information provision requirements to support safe use.

• Post-Market Obligations: Institutions using HIE must monitor device performance and report incidents, serious injuries or malfunctions in line with UK vigilance requirements.

• Regulatory Context: The guidance situates HIE within the UK Medical Devices Regulations and distinguishes it from the standard UKCA conformity route, emphasising that HIE is not a “shortcut” but an exception with specific duties.

The updated guidance helps institutions understand how to apply HIE responsibly while maintaining patient safety and regulatory compliance.

Link: https://www.gov.uk/government/publications/health-institution-exemption-for-general-medical-devices

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