At a Glance
- Authority: UK Medicines and Healthcare products Regulatory Agency (MHRA)
- Scope: CE‑marked medical devices and IVDs in Great Britain (England, Scotland, Wales)
- Key proposal: Indefinite recognition of EU MDR/IVDR CE‑marked devices, beyond 2030
- Consultation window: Open now, closes 10 April 2026
- Strategic impact: Major shift for EU‑cleared devices’ GB market access and UKCA strategy
What happened?
The UK MHRA has launched a targeted public consultation on proposals to allow indefinite recognition of CE‑marked medical devices in Great Britain, replacing the current time‑limited transition that was due to end by 2028–2030. The consultation, which runs until 10 April 2026, seeks feedback from manufacturers, clinicians, patient groups and other stakeholders on how long‑term CE recognition should work in practice.
Why does it matter?
Roughly 90% of medical devices in use in Great Britain are currently CE‑marked, so making CE recognition indefinite would materially reduce the risk of supply disruption and avoid a hard cut‑off that could pull products from the market. For medtech companies, the proposals would significantly reshape market access planning: EU‑cleared devices could continue to access GB without duplicate conformity assessments, reducing regulatory burden and changing how firms prioritise or time UKCA certification.
What exactly is MHRA proposing?
The consultation focuses on three core measures: extending current transitional arrangements for MDD‑certified devices in line with the EU’s own MDR transition; granting indefinite recognition to devices compliant with EU MDR and IVDR; and using an “international reliance” route for a subset of higher‑risk devices whose GB risk class would be higher than in the EU. Under the proposals, CE‑marked devices would still need MHRA registration and remain subject to UK post‑market surveillance rules, but would not require separate UKCA conformity assessment unless a sponsor chooses that route.
How does this affect medtech strategy?
If adopted, the policy would create a dual‑track system in which CE marking remains a long‑term gateway to the GB market, while UKCA is repositioned as a specialised route for first‑in‑market and highly innovative technologies (for example, some AI‑as‑a‑medical‑device products). For EU manufacturers, this means that maintaining MDR/IVDR compliance plus MHRA registration could be sufficient for GB access, substantially lowering incremental costs versus a standalone UK regime and influencing launch sequencing, portfolio decisions and notified‑body engagement strategies.
What’s next?
Until at least 10 April 2026, stakeholders can submit responses on issues such as which devices should qualify for indefinite recognition, how to handle higher‑risk classes and how UKCA and CE should coexist over the long term. After analysing feedback, the MHRA will finalise legislative proposals that could lock in CE recognition beyond 2030 and define the balance between streamlined access, international reliance and domestic innovation incentives, setting the regulatory context medtech companies will be planning against for the rest of the decade.