UK MHRA · June 29, 2026

Guidance: Borderline products: medical devices and other products

MHRA guidance on how it determines whether a borderline product meets the definition of a medical device and whether device regulations apply.

High obligation Framework Medical Devices & IVD Digital Health & AI UK Medical devicesDevice classificationSoftware as a medical device

How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.

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