How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
UK MHRA · June 29, 2026
Guidance: Borderline products – medical devices and other products
Original title: 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 medical device regulations apply.
Published by UK MHRA. HealthSignal links to the original document; the summary above is extracted from the source text.