Recognition of CE-marked medical devices in the UK

On 22 July 2025, the UK Government signalled that it is likely to pivot back to indefinite recognition of CE Marking of devices. In a welcome move, such devices would not need to undergo any additional review in order to be marketed in the UK.

This indication was included in UK Government’s response to the 2024 consultation on the future of the regulation of medical devices in the UK. The UK Government proposes a further consultation on the indefinite recognition of CE Marked devices later in 2025. However, it is now widely expected that this will result in indefinite recognition of CE Marks.

We understand that a small number of companies initiated the review of their CE Marked devices by a UK Approved Body in November, following publication of the MHRA consultation. These companies will be disappointed that these efforts now appear to have been wasted.

We set out below a brief timeline of how the UK’s position towards recognition of CE Marked devices has changed over the past four years.

A brief timeline of UK position on recognition of CE-Marked medical devices

January 2021

On Brexit Day, the UK continued to unilaterally recognise the CE Mark for a transitional period. We were then introduced to UKCA Mark which would replace the CE Mark in due course. Originally, the transitional period would expire in mid-2023 such that from 1 July 2023, all devices must bear a UKCA Mark in order to be placed on the GB market. This would be the case even if the device already bore a CE Mark. 

Later in 2021, a consultation was initiated regarding the future of medical device regulation in the UK. 

June 2022

The UK Government published its response to the 2021 consultation which indicated that the UK would continue to unilaterally recognise CE Marks until June 2026 (legacy Directive devices) or June 2028 (MDR devices).

October 2022 

The MHRA circulated a letter delaying the new regulatory framework by 12 months from July 2023 to July 2024. The implication was that the UK would continue to unilaterally recognise CE Marks until June 2027 (legacy Directive devices) or June 2029 (MDR devices).

March 2023

The then Government announced a proposal for an international recognition approval pathway. This new pathway would give CE Marked devices near-automatic access to the GB market, and might not need a UKCA Mark. Rather, it was assumed that the UKCA Mark would largely be reserved for novel devices that had not been approved elsewhere.

May 2023

The UK medical devices framework was formally amended (a matter of weeks before the theoretical deadline of 30 June 2023 announced in 2021) to extend the transitional periods during which CE Marked medical devices could continue to be commercialised in GB. The deadlines were now June 2028 (legacy Directive devices) or June 2030 (MDR devices).

At that time, many speculated that the UK might indefinitely extend unilateral recognition of the CE Mark. 

November 2024

The MHRA published a detailed consultation on future changes to the UK devices framework. This included four detailed routes to market for devices approved overseas. The route for most CE Marked devices (route 2) would require a second review by a UK Approved Body (in addition to the review by the Notified Body). This came as slight surprise in light of the speculation mentioned above.

July 2025

The UK Government published its response to the consultation and appears to have agreed to recognise the CE Mark indefinitely, abandoning the need for an additional UK-specific conformity assessment for devices that bear a CE Mark.