On October 21, 2026, the UK government confirmed it will continue to accept CE-marked medical devices and in vitro diagnostic devices in Great Britain on an indefinite basis.
Indefinite recognition of CE-marked devices allows patients in Great Britain to maintain access to medical technologies including insulin pumps, replacement joints, diagnostic tests, and surgical equipment without additional UK approval.
More than 90% of medical devices registered for use in Great Britain currently carry a CE mark indicating approval for the European Union market.
By recognizing European Union approved CE-marked medical devices, the UK regulatory framework avoids duplicate approval routes for manufacturers and prevents supply disruptions across Great Britain.
The UK government's decision to recognize CE-marked medical devices follows a public consultation conducted from February 16 to April 10, 2026, which received over 1,000 responses.
Medicines and Healthcare products Regulatory Agency Chief Executive Lawrence Tallon stated that recognizing CE-marked devices ensures patients in Great Britain maintain uninterrupted access to life-saving diagnostics and everyday treatments.
Steve Lee stated the Association of British HealthTech Industries looks forward to the implementation of CE mark recognition to support supply continuity and friction-free access to digital health technologies.
Under the UK regulatory framework, the Medicines and Healthcare products Regulatory Agency will oversee all medical devices on the UK market using post-market surveillance mechanisms including the Yellow Card scheme.
Executive Director of Regulation at the Association of British HealthTech Industries Steve Lee stated long-term recognition of CE marking provides regulatory predictability, safeguards patient access to HealthTech technologies, and avoids unnecessary duplication fundamental to UK industry investment decisions.
The Medicines and Healthcare products Regulatory Agency's 2030 Strategy aims to expand reliance and recognition routes with trusted regulators to reduce regulatory burdens and strengthen supply resilience.
The UK Conformity Assessed marking route continues to operate as the domestic approval pathway for medical devices in Great Britain alongside the CE mark recognition.
The UK government's regulatory approach for medical devices aligns with ambitions outlined in its Life Sciences Sector Plan and 10 Year Health Plan to support new health technologies.
The UK government is updating the UK Conformity Assessed route via a pre-market statutory instrument and seeking primary legislation to develop a future licensing framework for software and artificial intelligence medical devices.
The UK government's planned licensing framework for artificial intelligence medical devices reflects recommendations from the National Commission into the Regulation of AI in Healthcare.
The UK government announced it will conduct engagement sessions with patient groups, clinicians, and industry representatives to explain the implementation and oversight of the medical device arrangements.