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Written by Sarah Smith, MDR Specialist, Acorn Compliance

Medical device regulation is changing—fast. From the perspective of those working in the medical devices industry, the intersection of AI, software, and medtech is reshaping not just how we build devices, but how we bring them to market. The MHRA is pushing ahead with new reforms set to land in 2026, so we’ve outlined the changes you need to be prepared for. 

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What's Changing in 2026?

The MHRA’s upcoming regulatory reforms are all about updating the UK’s medical device rules in a post-Brexit world. The goal is to create a more current, responsive framework—one that stays in step with global standards while also giving innovative tech a smoother path to market.

A big focus is Software as a Medical Device (SaMD), especially when it includes AI. Like traditional medical devices, these tools need to prove they’re both safe and effective, and that includes handling any changes after deployment. Expect a risk-based, tiered approach, with different levels of scrutiny depending on what the device does and how it's used.

If you’re a manufacturer or working in a regulatory role, this means more emphasis on data—both pre- and post-market—and the need to demonstrate not just initial safety, but ongoing performance.

MHRA Regulation Innovation Office: Actually Helpful?

The MHRA has introduced a new function called the Regulation Innovation Office. Think of the function as a guide through the regulatory maze, especially useful for SMEs or academic teams who might not have a full-time RA function in-house.

This will help innovative projects avoid regulatory pitfalls before it is too late. It's a move towards proactive support instead of reactive red tape— this is a step in the right direction, recognising the need for innovative progress.

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AI Under the Microscope

AI tools are increasingly part of clinical workflows—but under the new Medical Device Regulation (MDR) requirements, they’ll face more scrutiny than ever. You must prove that the AI works, is consistent, and applicable in real-world settings, across diverse patient populations.

Transparency and explainability are key. Regulators want to know: 

• Can clinicians and patients understand how the AI makes decisions? 
• Can those decisions be audited?
• Can we be sure the system won’t go off-track after it’s deployed?

These are questions that need to be addressed early on in the development process if we want smoother approval processes later down the line.

AI Assisting with Regulation – Emerging Practices

Believe it or not, AI is now being used to help regulate AI. In some clinical trials for AI-driven medical devices, advanced algorithms are being used to monitor data quality, spot anomalies, and check for bias in real-time.

This means trials can run more efficiently, with fewer manual errors and quicker turnarounds. You can even simulate how different regulatory scenarios might play out before submitting to an agency. This insight is a game-changer for anyone involved in trial design or strategy.

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Real-World AI Use Cases We're Watching Closely

• ‍ Predicting COPD Flare-Ups‍
  
  • AI tools are being used to predict when patients with COPD might have an exacerbation. By analysing wearable data and health records, these systems can spot early warning signs and trigger pre-emptive care.
  • Regulatory focus: Is the predictive model accurate across different populations and settings? How does it handle new data inputs over time?
• ‍ LLMs in Radiology‍
  
  • Large Language Models (GPT-style AI) are showing up in radiology workflows. They help draft reports, suggest diagnoses, and link findings to prior scans.
  • Regulatory focus: Can clinicians verify the AI’s suggestions? Are we replacing human judgment—or augmenting it responsibly?
• ‍ Real-Time Performance Monitoring‍
  
  • Hospitals are deploying platforms that track how AI systems are performing day-to-day. These dashboards flag issues like performance drift, latency spikes, or high false positive rates.
  • Regulatory focus: This aligns with post-market surveillance goals. We need to show that performance is stable—and take action if it isn’t.
• ‍ Supporting Clinician Decisions‍
  
  • AI-driven clinical decision support systems (CDSS) are now embedded in many EHR systems. They help with diagnosis, medication selection, and care planning.
  • Regulatory focus: These tools must be explainable and clinically actionable. If a doctor can’t understand or trust the output, it’s not ready.

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The Future of Reforms: Staying Agile and Accountable

The regulatory landscape is evolving fast. Updates, documentation, and compliance procedures will now be the bare minimum for innovations to remain trustworthy and reliable. Coexisting alongside regulations as they change will ensure products and devices stay relevant.

The MHRA’s forthcoming reforms demonstrate a clear intent to support progress in medical technology while maintaining robust safeguards. Initiatives such as the introduction of Regulation Innovation Officers and the emphasis on continuous validation reflect a regulatory approach that is both thorough and adaptable.

From a regulatory strategy perspective, this evolution is both necessary and welcome. While it may demand greater diligence and preparation—particularly for AI-driven and software-based medical devices—it also promotes a more dynamic, transparent, and future-ready framework for healthcare innovation.

Artificial intelligence is not only transforming the capabilities of medical devices; it is also reshaping the regulatory methodologies used to assess and monitor them. Ensuring these systems are safe, effective, and trustworthy remains paramount—and staying ahead of these developments is essential for all stakeholders involved.

Are you stuck trying to prepare your Medical Device for upcoming regulation changes? Squirrel™ can help, making sure that you are notified every time you need to update your compliance. Plus, Squirrel™ is backed by the industry’s best MDR experts, like Sarah, who can help you out of any tough spot you find yourself in. All of this is covered by the industry’s only Compliance Warranty.

Book a free discovery call.

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