UKCA marking came into force in Great Britain in January 2021 when the UK left the European Union. UKCA Certification may be required for certain classifications of medical devices and is available from the UK appointed Approved Bodies, such as BSI (0086). There will be a transition period to 30 June 2023 to allow existing CE certifications to be replaced by the new UKCA mark. From 1 January 2021, medical devices must be registered with the MHRA before being placed on the UK market irrespective of whether UKCA marked or CE marked. Please refer to the timelines published by MHRA for the risk class of your medical device. A UK Responsible Person (UKRP) is required to be appointed if the manufacturer is based outside the UK.
For Northern Ireland, the EU MDR and IVDR will apply from 26 May 2021 and 26 May 2022, respectively. Even after 1 July 2023, a CE mark will continue to be required for medical devices placed on the Northern Ireland market and manufacturers will need to meet EU regulations.