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UK government confirms indefinite recognition of CE-marked medical devices

RA & medtech

Devices certified under the MDR or IVDR need no second approval in Great Britain; a new licensing model, including for AI, is still pending.

Source: Government confirms indefinite recognition of CE marked medical devices (MHRA, GOV.UK),

Note: I provide engineering services in regulatory affairs for medical devices.

Technical drawing: three routes run as arrows to a vertical line labelled GB. At the top, a CE file marked MDR and IVDR whose timeline runs from 2026 past the struck-out end date 06/2030, with an infinity sign above it; in the middle, a dashed box labelled LICENCE with a section sign and a question mark for a future licensing model; at the bottom, the parallel UKCA route.

What happened: On 21 October 2026, the UK government confirmed that Great Britain will recognise CE-marked medical devices and in vitro diagnostic devices (IVDs) indefinitely. So far this has only been a transitional arrangement, running to 30 June 2028 or 30 June 2030 depending on the device. According to the government response to a consultation with 1,056 responses, this covers devices certified under the EU MDR or IVDR. Older devices under the MDD directive will be accepted until the end of the EU transition period, which the government currently puts at 31 December 2028. The British UKCA route remains available.

What this means: With an MDR or IVDR certificate, you need no second approval for Great Britain (England, Scotland and Wales; Northern Ireland has its own rules), and that includes AI software. The British obligations stay in place: registration with the regulator MHRA, a UK Responsible Person (who is responsible for the devices on the UK market) for manufacturers based outside the UK, the post-market surveillance (PMS) requirements strengthened in June 2025, and technical documentation and certificate in English. The decision is not yet law: the legislative change needs parliamentary approval and is due before 30 June 2028. It brings no separate route for AI: for a future licensing approach that is also meant to suit software and AI better, the government still has to obtain powers through primary legislation.

What you can do:

  1. Review your UK plans: If you have budgeted an extra UKCA assessment for an MDR or IVDR device, put it under review. Until the change is passed, the existing deadlines still apply in law.
  2. Move legacy devices: MDD devices keep access to Great Britain only as long as they do in the EU. The transition to the MDR is still needed.
  3. Keep up the British obligations: Registration, the UK Responsible Person and PMS requirements continue to apply to CE-marked devices.
  4. AI software: Keep planning UK access via CE or UKCA. In its 21 October announcement, the government gives neither details nor a date for the licensing model; it has promised further detail on AI regulation by spring 2027.

Context: The government sees the step as part of the MHRA 2030 Strategy of 14 October, which aims to expand recognition of trusted regulators.

What does this mean for your team? Let’s talk it through. Request an intro call