UK Recognises CE-Marked Devices and IVDs Indefinitely ⚕️ Pure Clinical

No expiry date: Great Britain will keep accepting CE-marked devices and IVDs

On 21 October 2026, the UK Government confirmed that Great Britain will recognise CE-marked medical devices and in vitro diagnostic medical devices (IVDs) indefinitely. Two days later, MedTech Europe, the Association of British HealthTech Industries (ABHI) and the British In Vitro Diagnostics Association (BIVDA) welcomed the decision in a joint statement. Manufacturers with an MDR or IVDR certificate no longer face a cut-off date for CE marking in Great Britain.

For many manufacturers, the UKCA question has just disappeared

Many regulatory teams saw UKCA marking as a project they could put off but not avoid. They can now take it off the roadmap. A device certified under the MDR or IVDR can be placed on the GB market without a second conformity assessment. The government response says CE-marked products make up more than 90% of devices registered in Great Britain.

The UKCA mark is still available, but it becomes a strategic option rather than a condition of market access. A manufacturer might still choose it, for example, to launch an innovative product in the UK first. The three associations call the outcome “a pragmatic and proportionate approach”, because it avoids a second assessment of products the EU framework has already reviewed.

Timeline for CE recognition in Great Britain

Date	Process
February 2026	The MHRA opens a consultation on indefinite recognition.
21 October 2026	The government publishes its response, based on more than 1,000 submissions.
End of 2026	The draft Medical Devices (Amendment) Regulations 2026 are expected to be laid before Parliament. They are expected to take effect around autumn 2027.
30 June 2028	The current GB deadline for devices that comply with the Medical Devices Directive (MDD). The new legislation must be in force before this date.
31 December 2028	GB stops accepting MDD devices, in line with the current EU transition period.

Device classification will not block access. The consultation had proposed a separate reliance route for devices that the EU places in a higher risk class than UK MDR 2002 does. The final response dropped that proposal.

The EU certificate now carries twice the weight

The decision has a downside. Access to Great Britain depends on a valid EU certificate. If a notified body suspends or withdraws that certificate, the manufacturer loses both markets on the same day. Open nonconformities in the technical documentation therefore become a UK problem too.

The MHRA keeps its post-market surveillance role, including incident reporting and the Yellow Card scheme. The announcement does not change existing GB obligations. Manufacturers must still register devices with the MHRA, and manufacturers based outside the UK must still appoint a UK Responsible Person.

The industry associations have asked the MHRA for clear implementation guidance. Once it is published, manufacturers should check their GB processes against it.

Link to the document: CE-marking Recognition in UK