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UK MHRA · UK · 29 Jun 2026 · Guidance

Guidance: Borderline products: medical devices and other products

AI-generated summary

The UK MHRA updated its guidance on borderline products between medical devices and other products as of March 2024. The guidance now states that alcohol-only pre-injection swabs and wipes are medical devices, removing previous text about anti-microbial substances. A paragraph on in-house manufacturing was removed as content is superseded elsewhere. Updates reflect the extension of CE marked device acceptance on the GB market following the end of the Brexit transition period.

From UK MHRA

'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.

Removal of paragraph 20. In-house manufacturing from the Borderlines page. This content is superseded on other published guidance pages.

Updated 'Borderlines with medical devices and other products in Great Britain' guidance, as of March 2024.

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.

Updates to 'Borderlines with medical devices and other products'.

This has been updated due to the end of the Brexit transition period.

Excerpt from the official page. The original is authoritative.