Borderlines with medical devices and other products in Great Britain
Guidance on whether or not your product is a medical device.
Documents
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 This content is superseded on other published guidance pages.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.