The UK government has confirmed that Great Britain will recognise CE-marked medical devices and in vitro diagnostic devices indefinitely, removing the prospect of a mandatory additional approval route for products already authorised for the EU market.
The decision follows a public consultation held from 16 February to 10 April 2026, which attracted more than 1,000 responses from patients, healthcare organisations and industry. More than 90% of medical devices currently registered in Great Britain carry a CE mark, making continued recognition important for maintaining supply and patient access.
For regulatory affairs professionals, the announcement provides greater long-term certainty for market access planning and reduces the risk of duplicated conformity assessment activity. Manufacturers may continue to use CE marking as a route to the Great Britain market, while UKCA marking remains available as the domestic pathway.
The policy does not remove ongoing compliance obligations. The Medicines and Healthcare products Regulatory Agency (MHRA) will continue to oversee devices on the UK market under strengthened post-market surveillance and reporting requirements, including safety monitoring through the Yellow Card scheme and cooperation with international regulators. Regulatory teams should therefore maintain robust vigilance, incident reporting and market-monitoring processes for products supplied in Great Britain.
Further reform is also expected. The government plans a pre-market statutory instrument to modernise UKCA requirements and will seek powers for a future licensing approach designed to accommodate evolving technologies, including software and Artificial Intelligence medical devices. Organisations should monitor the detail and timing of these measures, assess their effect on product portfolios and regulatory strategy, and retain the capability to support both CE-based recognition and UKCA submissions where commercially appropriate.
Implementation will include continued engagement with patients, clinicians and industry. Although the decision reduces immediate uncertainty, regulatory affairs professionals will need to follow forthcoming legislation and guidance to understand operational requirements, transitional provisions and any product-specific implications.
Continued CE recognition also reflects the MHRA’s 2030 Strategy ambition to expand reliance and recognition routes with trusted regulators, reduce regulatory burden, strengthen supply resilience and support timely patient access.
The full consultation outcome is available on the MHRA website.
