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.
Applies to England, Scotland and Wales
Documents
Details
This guidance explains when a product would be considered a medical device within the terms of Part II of the Medical Device Regulations 2002.
This guidance is specific to products placed on the market in Great Britain (England, Wales and Scotland). Find out how medical devices are regulated in Northern Ireland.
Updates to this page
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Removal of paragraph 20. In-house manufacturing from the Borderlines page. This content is superseded on other published guidance pages.
Update history
2026-06-29 16:20
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.
2025-06-09 09:35
Removal of paragraph 20. In-house manufacturing from the Borderlines page. This content is superseded on other published guidance pages.
2024-04-08 14:05
Updated ‘Borderlines with medical devices and other products in Great Britain’ guidance, as of March 2024.
2023-07-01 00:01
File ‘updated in light of the extension of acceptance of CE marked devices on the GB market’ updated in light of the extension of acceptance of CE marked devices on the GB market.