On February 16, 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) opened a targeted consultation on proposals for the indefinite recognition of CE‑marked medical devices on the Great Britain market. One of the objectives of the proposals is to help secure the continued availability of medical devices for patients.
The consultation comes as part of a UK’s broader reform of its post‑Brexit medical device regulatory framework and follows several extensions of the current transitional arrangements.
Why CE marking remains relevant in Great Britain
According to the MHRA, around 90 % of medical devices currently used in Great Britain carry CE marking, which explains the repeated decisions to delay the mandatory use of the UK Conformity Assessed (UKCA) marking.
Under the current framework, CE‑marked medical devices and in vitro diagnostic medical devices are accepted in Great Britain only until defined end dates, depending on the applicable EU legislation and device class. The ongoing consultation explores whether this recognition should become indefinite.
Scope and participation of the consultation
The consultation applies only to Great Britain (England, Scotland, and Wales). Medical devices placed on the Northern Ireland market remain subject to EU medical device legislation and must continue to bear the CE marking.
The MHRA is seeking input from manufacturers, distributors, approved bodies, trade associations, healthcare professionals, and patient organisations. The consultation is open until April 10, 2026.
The proposals in brief:
The consultation focuses on three proposed changes:
- Aligning Great Britain transitional arrangements for EU Legacy devices (MDD-compliant) with EU timelines to reduce supply risks,
- Allowing indefinite recognition of CE‑marked devices compliant with the EU MDR or IVDR, and
- Introducing an international reliance route for a limited number of higher‑risk devices to avoid a full UKCA assessment.
What this could mean for manufacturers
If adopted, these changes could simplify market access for manufacturers already compliant with EU requirements. Indefinite recognition of CE marking would reduce regulatory duplication and provide greater predictability for companies supplying both the EU and Great Britain markets. At the same time, the MHRA has made clear that patient safety and post‑market surveillance would remain key priorities.
What happens next
Stakeholders can submit their views through the MHRA consultation channels until April 10, 2026.
The outcome of this consultation will be an indicator of how closely the UK intends to align with the EU medical device framework in the long term.
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References:
MDlaw. (2026). UK launches consultation on the indefinite recognition of CE‑marked devices in Great Britain. Retrieved on 16/03.2026
Medicines and Healthcare products Regulatory Agency. (2026). Medical devices regulations: targeted consultation on the indefinite recognition of CE marked devices. Retrieved on 16/03.2026.
Giulia Maria Trapanese
Regulatory Intelligence & Innovation
24/03/2026