UK consultation results in permanent recognition of CE mark for GB market entry

The UK government, via the Medicines and Healthcare products Regulatory Agency (MHRA) has now published its conclusions on the public consultation concerning the continued acceptance of CE marked devices in the Great Britain (GB) market, beyond the previously advised classification-dependent deadlines of:
• Class III/Class IIb implantable: 31 Dec 2027
• Class IIb other/Class IIa/Class I*: 31 Dec 2028
• IVDs: 31 December 2030
* Only Class I devices that will need the involvement of a notified body under the MDR.

On 21 October, the MHRA announced in a press release the results of the public consultation which ran from 16 February 2026 to 10 April 2026 (that received more than 1,000 responses from patients, healthcare organisations, industry and others). The conclusion from the consultation is that, with immediate effect, the UK government has confirmed it will continue to accept CE marked medical devices on a long-term basis.

This decision means the UK will not require an additional approval route for devices already cleared for the EU market, thus avoiding duplication for manufacturers.

More than 90% of medical devices registered for use in GB currently carry a CE mark, meaning they have been assessed and cleared for marketing in the European market, and this approval has now been recognised as also providing access to the GB market. This decision sits alongside the UKCA marking route, which continues to operate as the domestic approval pathway for devices intended to be placed only on the GB market.

Continued recognition of CE-marked devices also reflects the wider ambition of the MHRA’s 2030 Strategy to expand reliance and recognition routes with trusted regulators, reducing regulatory burden, strengthening supply resilience and supporting timely patient access.

The conclusions of the consultation are:

• Decision 1: The government intends to align the timelines for recognising devices approved under EU MDD with the EU timelines for devices to transition to EU MDR, so these devices will be accepted until the end of the EU transition period (currently, 31 December 2028). In addition, EU MDD-certified medical devices placed compliantly on the EU or Great Britain market prior to the end of the EU transitional arrangements will continue to be allowed on the Great Britain market, mirroring the approach taken in the EU.

• Decision 2: The government intends to indefinitely recognise all CE marked medical devices certified under EU MDR and EU IVDR.

For manufacturers with CE marked devices who have not yet started or completed the UKCA certification process, this is excellent news, as it will no longer be necessary to engage a UK Approved Body (for higher risk devices) – registration of the CE marked devices will be sufficient to allow them onto the GB market (Northern Ireland already accepts CE marked devices on a permanent basis).

For manufacturers with CE marked devices who have also achieved the UKCA mark for their products, the UKCA certification can be allowed to lapse, as it will no longer be required for GB market access.

Remember though that certain UK-specific requirements still apply, including:
• Designation of a UK Responsible Person (UKRP)
• Manufacturer and device registration
• Compliance with the UK Post-market Surveillance Regulation