UK Medical Device Regulation Changes 2025: What They Mean for Cybersecurity and Compliance

In June 2025, the UK introduced a landmark overhaul to its medical device regulations. While much of the focus has been on patient safety and post-market surveillance, there's a critical dimension that digital health and medtech companies must not overlook: cybersecurity. As connected devices become the norm in healthcare, the risks of cyber threats aren't just about data breaches anymore; they're patient safety issues. This blog explores how the new regulations intersect with cybersecurity and what healthcare innovators need to do next.

Why Cybersecurity Is a Patient Safety Issue

Medical devices are no longer standalone tools. Today, they're often cloud-connected, data-driven, and software-enabled. That means vulnerabilities in your code or server infrastructure can translate into real-world harm: a misfiring insulin pump, inaccurate diagnostic results, or even full device takeovers. The UK government and the MHRA (Medicines and Healthcare products Regulatory Agency) are increasingly treating cybersecurity as an integral part of device safety.

What the June 2025 Overhaul Introduced

The 2025 regulatory update focuses on post-market surveillance (PMS). While cybersecurity isn't the headline, it's woven into the logic of ongoing safety monitoring:

• Manufacturers must proactively track real-world device performance.

• Any serious incident—including one stemming from a cyber vulnerability—must be reported to the MHRA within 15 days.

• Trends of smaller issues, such as repeated app crashes or connectivity errors, must also be analysed and may require regulatory notification.

This effectively brings cybersecurity into the same regulatory domain as mechanical failures or usability issues.

Cybersecurity: The Next Regulatory Frontier

Although cybersecurity isn’t yet codified as a standalone requirement in the UK medical device rules, that’s changing fast:

• The MHRA has confirmed it will publish dedicated guidance on cybersecurity for Software as a Medical Device (SaMD) by the end of 2025.

• The UK government’s future roadmap explicitly includes cybersecurity as an "essential requirement" for all medical devices.

• NHS England already requires suppliers to demonstrate cybersecurity readiness during procurement.

What Digital Health Companies Should Do Now

1. Embed Cybersecurity in Design: Build threat modelling, secure coding practices, and encryption into the earliest stages of device and software development.

2. Treat Cyber Events as Safety Events: If a cyber vulnerability could impact patient health, report it just as you would a hardware failure.

3. Prepare for Patching and Communication: You may need to issue Field Safety Notices (FSNs) to inform users of security updates. Have a process in place.

4. Monitor Continuously: Include cybersecurity alerts and threat intel in your post-market surveillance activities.

5. Stay Aligned with Global Standards: To future-proof your compliance, follow ISO 81001-5-1, FDA guidance, and upcoming MHRA cybersecurity guidance.

Real-World Example

Imagine your wearable ECG device uses a mobile app that stores patient data in the cloud. A flaw in the app’s authentication system could allow unauthorised access to readings or even manipulation of alerts. Under the new PMS rules, this would be a safety risk that must be addressed, documented, and reported. This is why cybersecurity isn’t just an IT concern—it’s a compliance and safety imperative.

The UK’s 2025 overhaul of medical device regulations is just the beginning. For digital health companies, now is the time to bring cybersecurity front and centre. It’s no longer optional or separate from safety and compliance—it's core to both. Companies that act now to strengthen their cybersecurity posture will not only meet regulatory expectations but also earn trust in an increasingly connected healthcare system.

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