If you sell medical devices in Great Britain, the ground is shifting, but not in the direction many expected. Instead of forcing a hard switch to UKCA marking, the MHRA spent early 2026 consulting on recognising CE-marked devices for the long term. Here is where things stand and what to do about it.
Can you still sell CE-marked devices in Great Britain?
Yes, for now. About 90 percent of devices on the GB market carry CE marking rather than UKCA, so a sudden cut-off would threaten supply to the NHS. That reality has shaped every MHRA decision since Brexit. Under the current transitional rules, EU MDD-compliant devices are accepted in GB until 30 June 2028, and EU MDR and IVDR-compliant devices until 30 June 2030.
What did the MHRA 2026 consultation propose?
On 16 February 2026 the MHRA opened a targeted consultation, which closed on 10 April 2026. It carried three connected proposals. First, extend the MDD transitional deadline from 30 June 2028 to 31 December 2028, to line up with the EU timeline. Second, and most significant, recognise CE-marked devices that meet EU MDR or IVDR indefinitely, so they could stay on the GB market without a full UKCA assessment. Third, for the smaller set of devices that sit in a higher risk class under UK rules, offer a tailored international reliance route rather than full re-certification. The MHRA has said wider reforms to the UK framework will follow later in 2026.
What is the International Reliance Pathway?
It lets manufacturers use an existing EU approval, and in some cases FDA or other trusted approvals, to register with the MHRA instead of repeating the whole conformity assessment. The device does not get a UKCA mark through this route. It gets a certificate whose validity mirrors the underlying EU certification. There is a limit worth knowing. Self-declared Class I or Class A devices that would be up-classified under UK rules would not qualify, and would still need a UKCA assessment.
What about Northern Ireland?
Different rules apply. Under the Windsor Framework, Northern Ireland follows EU MDR and IVDR, CE marking is required, and UKCA is not recognised there. Treat GB and NI as two separate market-access questions rather than one UK question.
What should manufacturers do now?
Do not tear up your CE strategy. The direction of travel is toward keeping CE-marked devices on the GB market, not away from it. The sensible moves are practical ones. Confirm your transitional deadline by device type, since MDD, MDR, and IVDR devices sit on different clocks. Make sure your UK Responsible Person registration is current, because that obligation has not gone away. And watch for the reform package due later this year, which is expected to reshape the domestic route to market alongside the CE recognition decision.
Where does Network Partners Group fit?
For companies that would rather not track all of this alone, Network Partners Group works both the EU and UK routes as part of its Compliance practice. Its execution record on EU MDR is the relevant proof point. Its labeling group recently delivered an EU MDR update covering more than 100 instructions-for-use across 20-plus languages on deadline, closing two legacy CAPAs in the process, which is exactly the kind of EU MDR capability a GB market moving toward recognising EU MDR devices will keep needing. Its regulatory people also present at events like RAPS Convergence and the PDA FDA Joint Regulatory Conference, a reasonable proxy for whether a firm stays current on shifting rules. The value here is not a promise to make the rules simple. It is having someone who reads MHRA consultations for a living confirm your GB position against your device class and timeline. Teams that want that second read can reach regulatory affairs consulting at Network Partners Group.
Frequently asked questions
Is UKCA marking still required? Not right now for most devices. CE-marked devices are accepted under transitional rules until at least 2028 or 2030, and the MHRA is consulting on recognising CE marking for the long term. UKCA remains available if you choose it.
When do the current CE transitional deadlines end? EU MDD-compliant devices are accepted in GB until 30 June 2028, and EU MDR and IVDR-compliant devices until 30 June 2030, unless the proposed changes extend them.
Does a non-UK manufacturer still need a UK Responsible Person? Yes. A UK Responsible Person and MHRA registration are still required regardless of which marking route you use.
Do these UK changes apply in Northern Ireland? No. Northern Ireland follows EU MDR and IVDR under the Windsor Framework, where CE marking is mandatory and UKCA is not recognised.
