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Placing medical devices on the UK market after the end of Brexit transition

UKCA mark and Northern Ireland mark (UKNI)

Manufacturers who are not supplying the EU/EEA markets might prefer the UK regulatory system to the EU's. Additionally, all device manufacturers will need to start to transition to the UK system in advance of the deadline of 30 June 2023. We have very little information on that new system except for the following:

  • There will be UK Approved Bodies (equivalent to EU notified bodies) and notified bodies previously authorised under the EU Directives will automatically qualify for this role.

  • There is to be a new UKCA mark to be added to a device that conforms with the UK regulatory system and which cannot be used in the EU, EEA or (on its own) in Northern Ireland.

  • Devices solely destined for the market in Northern Ireland and following the UK authorisation process must be labelled with the UKNI mark, which similarly cannot be used on devices destined for the market in the EU or EEA but can be combined with the UKCA mark in Northern Ireland.

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