UKCA marking came into force in Great Britain in January 2021 when the UK left the European Union.
From this date to June 2024, Medical Devices and IVDs can be marked with either CE or UKCA. From July 2024, legislative transitional arrangements will apply for CE and UKCA marked Medical Devices and IVDs placed on the Great Britain market.
*Please note this represents current timelines that might be subject to change after New UK Regulation enters in force.
For Northern Ireland, even after July 1, 2024, a CE or UKNI mark will continue to be required for medical devices placed on the NI market and manufacturers will need to meet EU Regulations.