Original document : https://www.gov.uk/government/publications/borderlines-with-medical-devices

Change description : 2025-06-09 09:35:00: Removal of paragraph 20. In-house manufacturing from the Borderlines page. This content is superseded on other published guidance pages. [Guidance and regulation]

Showing diff : 2024-04-08 13:05:39.643800544 +00:00..2025-06-09 08:36:40.260937297 +00:00

Guidance

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
89 AprilJune 20242025 — See all updates

Applies to England, Scotland and Wales

Documents

Borderlines with medical devices and other products in Great Britain

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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

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Update history

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 This content is superseded on other published guidance pages.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.