UK medical device market keeps CE recognition indefinitely

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UK keeps CE medical device access

Highlights

UK government will indefinitely accept CE marked medical devices, removing duplicate approval for over 90% of devices registered in Great Britain.
Continued CE recognition ensures supply stability, avoids disruptions to patient access, and provides greater investment predictability for manufacturers in the UK medical device market.
The policy supports UK competitiveness and aligns with broader reforms under the Life Sciences Sector Plan and MHRA 2030 Strategy, including stronger post-market surveillance and preparation for AI-powered devices.

Regulatory framework and approval routes

As reported by GOV.UK, the government confirms it will continue accepting CE marked medical devices on an indefinite basis after a public consultation that drew more than 1,000 responses from patients, healthcare organisations, industry and other stakeholders.

The policy means manufacturers do not face a duplicate approval process for devices already approved for the EU market. More than 90% of medical devices registered for use in Great Britain currently carry a CE mark, making the decision significant for products ranging from insulin pumps and replacement joints to surgical equipment and diagnostic tests.

The UKCA route remains the domestic approval pathway for devices placed on the market in Great Britain. The government says that system is being modernised through a pre-market statutory instrument that will update the requirements devices must meet to obtain UKCA marking.

Supply stability and sector impact

The government says continued recognition of CE-marked devices supports stable supply, avoids disruption to patient access and gives manufacturers greater regulatory predictability when making investment decisions. The arrangements also sit alongside strengthened post-market surveillance and reporting rules, with the Medicines and Healthcare products Regulatory Agency continuing to oversee devices on the UK market and monitor safety through tools including the Yellow Card scheme.

Lawrence Tallon, chief executive of the MHRA, says the decision gives patients, the NHS and industry long-term certainty while broader reforms prepare the regulatory system for newer technologies, including AI-powered medical devices. Steve Lee, executive director for regulation at ABHI, says long-term CE recognition is a significant step for HealthTech companies because it reduces unnecessary duplication and supports the UK's competitiveness as a market for new medical technologies.

The government also says it will continue engaging with patients, clinicians and industry as the arrangements are implemented, including sessions with patient groups on safety and oversight. Officials position the change as part of the government's Life Sciences Sector Plan, the 10 Year Health Plan and the MHRA's 2030 Strategy to widen recognition routes with trusted regulators while strengthening supply resilience.

Our earlier article on AstraZeneca’s AI-driven drug discovery partnership with insitro described a multi-year collaboration aimed at identifying new targets for hard-to-treat liver and heart diseases, with deal terms that could reach about $1.5 billion including milestones. We noted that insitro’s “Virtual Human” platform is intended to speed up early-stage research by combining lab models with machine learning, underscoring how AI is becoming central to life-sciences R&D and shaping how companies prioritize innovation.

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