UK Medical Device Regulation: What’s Changing & What You Need to Know
UK updates medical device rules: phased rollout, extended CE acceptance, stronger post-market surveillance from June 2025, more safety and innovation.
The UK government is rolling out a modernised regulatory framework for medical devices to strengthen patient safety, support innovation, and keep the UK market competitive.
Phased Implementation of New Rules
New regulations will be introduced gradually through secondary legislation. The first set, covering post‑market surveillance, was laid in 2024 and will take effect in June 2025. Additional statutory instruments in 2025–2026 will introduce enhanced pre‑market requirements, including international reliance pathways.
Transitional Arrangements for CE‑Marked Devices
To avoid market disruption, the UK has extended acceptance of CE‑marked devices on the Great Britain market under defined timelines:
Devices under older EU directives may be sold until certificate expiry or mid‑2028/2030 depending on the category.
Self‑declared Class I devices and certain sterile devices have specific extended allowances.
Stronger Post‑Market Surveillance (PMS)
From 16 June 2025, manufacturers must strengthen how they monitor devices already in use, with clearer requirements for:
Safety data collection and trend reporting
Enhanced incident reporting
Field safety corrective actions and notices
Regular reviews of surveillance data, especially for implantable devices.
This aims to help regulators identify and act on safety issues faster.
What’s Coming Next
Future regulations under development will further improve the regime by:
Up‑classifying certain devices (like implantables and software)
Requiring unique device identifiers (UDI)
Strengthening technical documentation and evidence requirements
Introducing a framework to recognise approvals from comparable international regulators
Harmonising key standards with EU rules, including cybersecurity provisions for software and AI‑enabled devices.
Supporting Guidance
New guidance is being co‑developed with industry and stakeholders to help manufacturers interpret and meet the updated regulatory requirements.
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About the Author
Global Market Access Consultant
Martin Churches is a global market access specialist with over a decade of experience supporting exporters, importers, and manufacturers through complex certification and regulatory requirements, combining technical expertise with strong client management.
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