UK MHRA · December 17, 2025

Guidance: Health Institution Exemption for general medical devices

Guidance for health institutions manufacturing general medical devices under the Health Institution Exemption.

High obligation Sector Medical Devices & IVD UK Medical devicesCE marking

Guidance for health institutions that manufacture general medical devices under the Health Institution Exemption (HIE).

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