GuidanceMHRA
Borderline products: medical devices and other products
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
First published: Jan 19, 2015Last updated: Jun 29, 2026Changes: 7
Latest change: The line: 'Alcohol-only pre-injection swabs and wipes are considered to be medical devices as are those containing anti-microbial substances such as chlorhexidine, cetrimide or iodine.' has been changed to this: Alcohol-only pre-injection swabs and wipes are considered to be medical devices.
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