Medical devices sold in Great Britain can currently carry either a UKCA mark or a valid CE mark. CE-marked devices are accepted for a limited period: until 30 June 2028 for devices certified under the older EU directives, and until 30 June 2030 for devices certified under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The MHRA has consulted on recognising CE marks indefinitely, but no decision had been published when we last checked on 21 September 2026.
If you buy medical devices for an NHS trust, private hospital or clinic, this guide explains what the two marks mean and what to check.
What is CE marking?
CE marking shows that a medical device meets the requirements of EU medical device legislation. It is the route used across the EU and EEA, and higher-risk devices are assessed by an EU notified body before they can be marked. In Great Britain, CE-marked devices are accepted under transitional arrangements set by the MHRA, described below.
What is UKCA marking?
The UKCA (UK Conformity Assessed) marking is a UK product marking used for certain goods, including medical devices, placed on the Great Britain market (England, Wales and Scotland). It is not recognised in the EU, the EEA or Northern Ireland.
Most devices that need a third-party assessment must be assessed by a UK Approved Body. Manufacturers of non-sterile, non-measuring Class I devices and general in vitro diagnostic devices can self-certify against UKCA requirements.
UKCA vs CE at a glance
- Where it applies: UKCA applies to Great Britain. CE applies across the EU and EEA, and is required for Northern Ireland.
- Who assesses higher-risk devices: a UK Approved Body for UKCA, an EU notified body for CE.
- Recognised in the EU and Northern Ireland: CE yes, UKCA no.
- Status in Great Britain: both are currently accepted, but CE acceptance has end dates.
How long can CE-marked devices be sold in Great Britain?
The MHRA sets these limits:
- General medical devices under the older EU directives (MDD and AIMDD): until the sooner of the certificate expiring or 30 June 2028.
- In vitro diagnostic devices under the older EU directive (IVDD): until the sooner of the certificate expiring or 30 June 2030.
- Devices under the EU MDR and IVDR: until 30 June 2030.
For devices certified under the older directives, the “sooner of” wording matters: acceptance ends when the certificate expires if that is before the date above.
What about Northern Ireland?
CE marking is required for the Northern Ireland market. Where a UK notified body carries out a mandatory third-party assessment, a UKNI indication is also needed alongside the CE mark.
What may change?
From 16 February to 10 April 2026 the MHRA consulted on proposals that would:
- recognise devices that comply with the EU MDR and IVDR indefinitely;
- extend the current transitional arrangements for devices certified under the old directive (MDD), in line with the EU’s own timelines for moving to the MDR; and
- introduce an international reliance route for devices classified higher in Great Britain than in the EU.
The MHRA says around 90% of medical devices used in Great Britain are CE marked. No outcome had been published on the consultation page when we last checked on 21 September 2026. Until a decision is made, the deadlines above stand.
What should UK buyers check?
- The mark and its status. The device carries a valid CE or UKCA mark (and a UKNI indication where it applies).
- The certificate expiry date. For devices certified under the older directives, CE acceptance ends at the sooner of certificate expiry or the dates above.
- MHRA registration. All medical devices must be registered with the MHRA before they are placed on the Great Britain market.
- A UK Responsible Person. Manufacturers outside the UK must appoint a single UK Responsible Person for all their devices.
- The paperwork. Ask your supplier for the declaration of conformity and the certificate details for anything you buy.
This guide is general information and is not legal advice. Check the MHRA guidance for your specific device, and speak to your supplier about the compliance documents for the products you buy.
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Frequently asked questions
Is UKCA marking mandatory for medical devices in Great Britain?
Not at present. CE-marked devices can still be placed on the Great Britain market during the transitional periods above, so UKCA is not yet the only route.
Can I still buy CE-marked medical devices in the UK?
Yes. CE-marked devices are accepted in Great Britain until 30 June 2028 for devices certified under the old directives (MDD and AIMDD), and until 30 June 2030 for devices under the EU MDR and IVDR and for IVDD devices. For devices certified under the old directives, acceptance ends when the certificate expires if that is before the date.
What is the difference between CE and UKCA marking?
CE is the EU and EEA conformity mark and is required in Northern Ireland. UKCA is the UK mark for Great Britain and is not recognised in the EU, the EEA or Northern Ireland. Higher-risk devices are assessed by an EU notified body for CE and a UK Approved Body for UKCA.
Do I need UKCA marking for Northern Ireland?
No. UKCA is not recognised in Northern Ireland. CE marking is required, plus a UKNI indication where a UK notified body did the mandatory third-party assessment.
What is a UK Responsible Person?
A UK-based person that non-UK manufacturers must appoint to act for all their devices on the Great Britain market. They must hold written evidence of the manufacturer’s authority.
Will CE marking be recognised in the UK indefinitely?
The MHRA consulted on this from 16 February to 10 April 2026. No decision had been published when we last checked on 21 September 2026, so the current deadlines apply.