The Government has confirmed it will continue to accept CE marked medical devices and in vitro diagnostic devices ('IVDs') on a long-term basis. This decision means the UK will not require an additional approval route for devices which have already been approved for the EU market. This welcome announcement avoids regulatory duplication for manufacturers and helps to maintain a stable supply of products for patients so they can access medical devices.
The long debate over the future of CE marking
As more than 90% of medical devices registered for use in Great Britain currently carry a CE mark, this confirmation of the long-term acceptance of CE marking is of fundamental importance to manufacturers, suppliers and patients.
Since Brexit, there have been a number of extensions to the standstill period during which CE marking was accepted in the UK. Now the Medicines and Healthcare Products Regulatory Agency ('MHRA') have confirmed that products that are approved for the European market will be recognised and can access the Great Britain market. Crucially, this will help maintain safe, uninterrupted access to the devices, IVDs and software and AI technologies that patients and the NHS rely on.
This decision follows a public consultation. The unsurprising outcome helps support the development and availability of new health technologies for patients, in line with the ambitions of the Government’s Life Sciences Sector Plan and the 10 Year Health Plan. Continued recognition of CE-marked devices also reflects the wider ambition of the MHRA's 2030 Strategy, announced in October 2026, to expand reliance and recognition routes with trusted regulators and to reduce regulatory burden and strengthen supply chain resilience.
This long-term acceptance of CE marking will sit alongside the UKCA marking route, which continues to operate as the domestic approval pathway for devices placed on the market in Great Britain. This is currently subject to reform through the pre-market statutory instrument, which will update the requirements devices must meet to be UKCA marked.
Alongside this, the MHRA are also seeking enabling powers through primary legislation to develop a future licencing framework for medical devices, whereby medical devices placed on the GB market through a domestic route would require a licence issued by the MHRA, rather than relying upon third-party conformity assessments.
Comment
While this decision was supported and expected by manufacturers, suppliers and patients alike, the confirmation that ten years of regulatory uncertainty is ended is to be welcomed. This indefinite recognition of CE marking will provide regulatory assurance and save costs caused by duplication of conformity processes. It will be a boost to the medtech sector and will help providers ensure safe patient care is available.
