Today, 16 February 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) opened an important consultation seeking views on proposed changes to the recognition of CE‑marked medical devices in Great Britain (GB). The initiative forms part of the UK’s ongoing efforts to refine its post‑Brexit regulatory landscape and ensure continued patient access to safe, effective medical technologies. The consultation invites feedback from a broad range of stakeholders, including manufacturers, distributors, clinicians, procurement bodies, trade associations, regulatory specialists, and patient organisations. It follows the UK government’s response in July 2025 to its consultation on routes to market for medical devices and IVDs, which outlined, among other initiatives, details of a future international reliance scheme – see our previous blog post on this for more information.

The consultation sets out three significant proposals:

  • First, the MHRA is considering extending the existing transitional arrangements (currently due to end on 30 June 2028) for devices certified under the former Medical Devices Directive (MDD), aligning them with the EU’s transition timelines to the Medical Devices Regulation 2017/745 (EU MDR). See our Advisory for details on current EU transition periods. This would mean that devices approved under the MDD, likely in the process of transitioning to the EU MDR, could continue to be placed on the GB market until 31 December 2028, rather than 30 June 2028 under the current rules. The consultation confirms that, if the EU further extends its transition periods, these would also apply in GB.
  • Second, the MHRA proposes the indefinite recognition of devices compliant with the EU MDR and the In Vitro Diagnostic Medical Devices Regulation 2017/746 (EU IVDR). Currently, recognition is due to end on 30 June 2030, after which only UKCA‑marked devices would be accepted in GB. The MHRA is seeking views on whether indefinite recognition should apply to:
    • all devices, meaning EU MDR/IVDR classification rules would be accepted in GB; or
    •  only devices that fall into the same or a lower risk class under UK MDR 2002, meaning GB classification rules would take precedence in cases where the device classification is higher under UK MDR.

MHRA registration and post‑market surveillance requirements would still apply, but additional approved body checks would not be required, and the device would continue to be monitored by the EU notified body in accordance with EU regulations.

  • Third, the consultation requests views on a proposed international reliance route for devices that comply with the EU MDR or EU IVDR but are classified at a higher risk level under UK MDR 2002. This would sit alongside the government’s earlier commitment, as set out in its consultation response from July 2025, to implement three proposed international reliance routes in relation to eligible devices with approvals in Australia, Canada, and the USA, when certain conditions are met. The newly proposed route relates specifically to the EU and aims to reduce regulatory duplication and smooth market access. Manufacturers could continue to use the existing transitional arrangements until 30 December 2030, after which they may access the GB market either via this international reliance route or through UKCA conformity assessment. Eligibility and the proposed review process are set out in Annex B to the consultation. Under the proposed model, manufacturers would receive an international reliance certificate, enabling them to register their device with the MHRA and place it on the GB market. Importantly, this certificate would not serve as a UKCA mark, and its validity would mirror the duration of the relevant EU MDR or EU IVDR certification. However, the route would not be available to all devices. Products that are self‑declared under the EU system but would be placed in a higher risk class in GB, such as CE‑marked Class I devices up‑classified to Class IIa, or Class A IVDs that would fall into a higher classification in GB, would not qualify and would instead need to undergo a full UKCA conformity assessment.

These proposals, if implemented, would provide long‑term certainty for medical device supply in Great Britain, reduce regulatory friction for global manufacturers, and support more proportionate, risk‑based oversight, all while maintaining alignment with international best practice. Stakeholders have until 10 April 2026 to submit responses via the MHRA’s online portal, email, or post.