GuidanceMHRA
Health Institution Exemption for general medical devices
Guidance for health institutions that manufacture general medical devices under the Health Institution Exemption (HIE).
First published: Dec 17, 2025Last updated: Jan 20, 2026Changes: 2
Latest change: Removed the sentence: " the MHRA will not consider this as an enforcement priority currently, provided the leading practice guidelines are followed" from General Information on Health Institution's premises.
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