RegulatoryOfficial

MHRA to proceed with indefinite GB recognition of CE marked MDR and IVDR devices

🇬🇧 MHRA · Wed 21 Oct 2026

Following a consultation that drew 1,056 responses, the government intends to legislate for indefinite recognition and to align MDD transition timelines in Great Britain with the EU's.

The MHRA has published the government response to its targeted consultation on recognising CE marked medical devices in Great Britain. The document, dated 21 October 2026, says the government intends to bring forward legislative changes to recognise indefinitely devices certified under the EU Medical Devices Regulation 2017/745 (EU MDR) and the In Vitro Diagnostic Regulation 2017/746 (EU IVDR). This replaces the earlier position, in which the consultation was still open.

The government also intends to align GB transitional arrangements for devices compliant with the EU Medical Devices Directive 93/42 with the EU timelines for moving from the Directive to the MDR. The stated aims are continuity of supply, continued patient access to safe and effective devices, and lower administrative burden for manufacturers.

The consultation ran from 16 February to 10 April 2026. Respondents included device and IVD manufacturers, UK responsible persons, approved and notified bodies, healthcare professionals, patient groups and individuals. A majority backed both the extension of the transition for Directive-compliant devices and indefinite recognition of MDR and IVDR devices, citing avoided supply disruption, less duplicated regulation and support for the UK MedTech sector. Some stakeholders raised concerns about oversight, accountability and the UK's ability to assure safety and performance independently.

A third proposal, an international reliance route for devices classified higher in GB than in the EU, found little support. Most respondents said it would add complexity out of proportion to any safety benefit. The government's stated intention covers the first two proposals only, and the response text does not say what will happen to the reliance route.

CE marked devices on the GB market will still have to meet domestic requirements, including a UK responsible person, MHRA registration and post-market surveillance obligations. The MHRA says it remains responsible for monitoring the safety of all devices in the UK, whatever their route to market. The proposals apply to Great Britain, with Northern Ireland covered by separate guidance. The government says indefinite recognition also supports supply to Northern Ireland, because manufacturers can place the same product on the UK-wide market.

What it means for your team

  • Manufacturers relying on CE marking under the EU MDR or IVDR can plan for open-ended GB access, but the legislation has still to be brought forward and no dates are given in the response.
  • Companies with legacy Directive-certified devices should expect their GB transition to follow EU deadlines, and should track the EU timelines closely.
  • UK responsible person, MHRA registration and post-market surveillance obligations remain in place, so GB vigilance and PMS processes should not be scaled back.
  • No GB-specific reliance route is announced for devices classified higher in GB than in the EU, so classification differences should be monitored.

Official source: MHRA ↗

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

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