Buyer's Guides
CE & UKCA Marking for Medical Devices: What UK Buyers Need to Know
What CE and UKCA marks mean for medical devices, how they differ after Brexit, device risk classes, and what to check before you order.
OMS Clinical Team
Product Specialists
If you buy medical devices in the UK, two conformity marks matter: CE and UKCA. This explainer sets out what each means, how they differ after Brexit, and what to check before you order.
What the marks mean
A CE or UKCA mark is the manufacturer's declaration that a device meets the relevant safety, quality and performance requirements and can lawfully be sold.
| Mark | Market | Regulation |
|---|---|---|
| CE | EU / Northern Ireland (accepted in GB during transition) | EU MDR 2017/745 |
| UKCA | Great Britain | UK MDR 2002 (as amended) |
CE vs UKCA after Brexit
Great Britain continues to recognise CE-marked devices for an extended transition period, so you will still see CE marks. UKCA is the GB equivalent. Northern Ireland uses CE under the Windsor Framework.
