UKCA stands for UK Conformity Assessed. It is the conformity marking used for goods placed on the market in Great Britain, introduced after the UK left the European Union to replace the CE marking in that territory. For medical devices it signals that the manufacturer has demonstrated compliance with the applicable UK regulations and, where required, has done so with the involvement of a UK Approved Body.
Northern Ireland is treated differently under the terms of the Windsor Framework, where EU rules continue to apply and the CE marking or the UKNI marking is used instead. Manufacturers selling across the whole of the UK therefore need to understand which marking applies in which part of the country.
The UK equivalent of an EU Notified Body is an Approved Body, designated by the Medicines and Healthcare products Regulatory Agency (MHRA). Their involvement is required for all but the lowest risk devices, and the pool of designated organisations is considerably smaller than in the EU, which has been a practical bottleneck for manufacturers seeking assessment capacity.
The UK has repeatedly extended recognition of CE marked medical devices for the Great Britain market to avoid supply disruption while a reformed post-Brexit framework is developed. Because these dates have moved more than once and vary by device type and by the EU legislation the device was certified under, manufacturers should always confirm the current position directly against MHRA guidance rather than relying on secondary sources.
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