MHRA updates guidance on the Health Institution Exemption to support safe use of medical devices

18th December 2025

MHRA updates guidance on the Health Institution Exemption to support safe use of medical devices

Summary: Published on 17th December 2025, this MHRA update sets out clearer “leading practice” guidance on when and how the Health Institution Exemption can be applied, supporting hospitals and other health institutions to manufacture new devices or modify existing ones to meet specific clinical needs (for example specialist dosing software or communication aids). It follows a recent survey and highlights five core principles for health institutions: maintaining quality management systems, ensuring device traceability, meeting essential requirements, keeping technical documentation, and ongoing monitoring of device performance. The guidance also adds practical scenarios to aid day-to-day decision-making, clarifies which organisations are in and out of scope, explains expectations where third parties manufacture on a health institution’s behalf, and simplifies key terms to reduce misunderstandings. It applies to general medical devices only (not IVDs), encourages checking whether suitable products already exist before developing in-house, and reminds organisations to inform patients when a device is made under the exemption and to report safety concerns via the Yellow Card scheme. 

Link: MHRA updates guidance on the Health Institution Exemption to support safe use of medical devices

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