CE marking, previously used across the UK and wider Europe, entered a new phase after Brexit. From 1 January 2021 the UK introduced its own UKCA marking scheme, which applies to Great Britain (GB) only.

From that date, all medical devices placed on the UK market must be registered with the MHRA.

Under “Regulating medical devices in the UK”, manufacturers based outside the UK who wish to supply devices to GB (England, Scotland, Wales) must appoint a UK-based authorised representative. Only that representative may register the device with the MHRA.

During the grace period, CE marking remains accepted in GB, but from 1 July 2023 CE marking ceases to be valid for medical devices in GB and UKCA becomes the sole mark demonstrating conformity for market placement. Exporters must understand UK agent appointment and the certification path for each device class.

UKCA (UK Conformity Assessed) is the conformity scheme introduced for England, Wales and Scotland after the UK left the EU.

CE certification is no longer accepted for medical devices in GB from 1 July 2023; UKCA is required for lawful distribution in the UK market.

Northern Ireland continues to accept CE marking under the Belfast Agreement. UKCA therefore applies only in Great Britain (England, Wales and Scotland).

All medical devices sold in the UK must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA).

If the manufacturer is not established in the UK, a UK-based Responsible Person must be appointed to carry out MHRA registration.

UKCA requirements currently align with the former CE route for medical devices.

The UK plans further secondary legislation to establish an independent framework based on UK MDR 2002.

Affixing the UKCA mark indicates that the product or manufacturer meets the essential requirements of UK MDR 2002.

The mark is valid only in England, Wales and Scotland.