UK MHRA · December 17, 2025

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

MHRA updated guidance on the Health Institution Exemption to help NHS Trusts and health institutions safely design and manufacture general medical devices.

High obligation Sector Medical Devices & IVD UK Medical devicesCE marking

Updated MHRA guidance will help health institutions, such as NHS Trusts and Boards, safely design and make general medical devices for patients.

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Published by UK MHRA. HealthSignal links to the original document; the summary above is extracted from the source text.