BorderlinesBorderline withproducts: medical devices and other products in Great Britain
Guidance
How the MHRA makes decisions on whether ora notborderline your product is a medical device.device and whether medical devices regulations should apply.
- From:
- Medicines and Healthcare products Regulatory Agency
- Published
- 19 January 2015
- Last updated
-
89AprilJune20242025 — See all updates
Applies to England, Scotland and Wales
Documents
Details
This documentguidance givesexplains helpwhen ina workingproduct outwould ifbe yourconsidered producta medical device within the terms of Part II of the Medical Device Regulations 2002.
This guidance is consideredspecific to beproducts aplaced on the market in Great Britain (England, Wales and Scotland). Find out how medical devicedevices underare UKregulated legislation.in Northern Ireland.
Updates to this page
Published 19 January 2015
Last updated 89 AprilJune 2024
+ show2025
href="#full-history">+ show all updates
-
Sign up for emails or print this page
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 This content is superseded on other published guidance pages.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.
Details
This documentguidance givesexplains helpwhen ina workingproduct outwould ifbe yourconsidered producta medical device within the terms of Part II of the Medical Device Regulations 2002.
This guidance is consideredspecific to beproducts aplaced on the market in Great Britain (England, Wales and Scotland). Find out how medical devicedevices underare UKregulated legislation.in Northern Ireland.
Updates to this page
Published 19 January 2015
Last updated 89 AprilJune 2024
+ show2025
href="#full-history">+ show all updates
-
Sign up for emails or print this page
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.
Details
This documentguidance givesexplains helpwhen ina workingproduct outwould ifbe yourconsidered producta medical device within the terms of Part II of the Medical Device Regulations 2002.
This guidance is consideredspecific to beproducts aplaced on the market in Great Britain (England, Wales and Scotland). Find out how medical devicedevices underare UKregulated legislation.in Northern Ireland.
Updates to this page
Sign up for emails or print this page
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.