Market accessOfficial

UK confirms indefinite recognition of CE marked medical devices in Great Britain

🇬🇧 MHRA · Wed 21 Oct 2026

The government has decided CE marked devices and IVDs approved for the EU will keep access to the GB market long term, following a consultation with over 1,000 responses.

The UK Government announced on 21 October 2026 that it will continue to accept CE marked medical devices and in vitro diagnostic devices (IVDs) in Great Britain on a long-term basis. The MHRA said the decision means no additional approval route will be required for devices already approved for the EU market, avoiding duplication for manufacturers.

The decision follows a public consultation that ran from 16 February to 10 April 2026 and drew more than 1,000 responses from patients, healthcare organisations, industry and others. The MHRA noted that over 90% of devices registered for use in Great Britain currently carry a CE mark.

The UKCA marking route remains the domestic approval pathway for devices placed on the GB market. The MHRA said it is being modernised through the pre-market statutory instrument, which will update the requirements devices must meet to be UKCA marked. The government also plans to keep seeking enabling powers in primary legislation to develop a future licensing approach for medical devices, with software and AI medical devices cited as a focus, reflecting recommendations from the National Commission into the Regulation of AI in Healthcare.

On safety, the agency said the recognition sits alongside strengthened post-market surveillance and reporting requirements already in place. The MHRA will continue to oversee all devices on the UK market, monitor safety through mechanisms including the Yellow Card scheme, and share safety information with international partners. Steve Lee of ABHI welcomed the decision as providing much-needed certainty for manufacturers, while MHRA Chief Executive Lawrence Tallon said it gives patients, the NHS and industry long-term certainty. The government plans engagement sessions with patient groups on safety and oversight as the arrangements are implemented; the release does not set out detailed implementation steps.

What it means for your team

  • Manufacturers with CE marked devices or IVDs can plan for GB market access without a separate additional approval route, and without an end date for recognition.
  • UKCA remains available as the domestic route, and the pre-market statutory instrument will update the requirements for UKCA marking, so teams using that route should watch for its details.
  • Post-market surveillance and reporting obligations remain in place, with the MHRA citing the Yellow Card scheme and international information-sharing, so vigilance processes still need to cover GB.
  • The release gives no detailed conditions or implementation steps, so teams should check the full government response and consultation outcome on GOV.UK.

Official source: MHRA ↗

Article written by VigiEye from the official source (MHRA). AI-assisted; check the source before acting.

More Market access All →