Same Innovation, Different Pathways: AI Regulation in the US, EU & UK

AI Medical Devices Face an Uneven Playing Field
AI-enabled Medical Devices Obligations Across US, EU, and UK
From Rules to Reality
Key Takeaways

In the fast-evolving world of Diagnostics and Medtech, regulatory strategy can be as crucial as the innovation itself. For companies developing AI-enabled medical devices, understanding the differences between US, EU, and UK regulations isn’t just a compliance exercise – it’s a strategic advantage that can dramatically accelerate your route to market.

This topic will be a key talking point at HTLH taking place in Las Vegas next week, and we’re delighted to share the thoughts of our expert colleagues from CS LifeSciences, an Abingdon Health group company, on the evolving landscape within AI Regulation.

CS LifeSciences specialises in helping innovators overcome regulatory complexity and turn it into commercial opportunity across the IVD and Medtech markets. CS LifeSciences’ team of regulatory experts guide you through every jurisdiction’s unique requirements; ensuring your breakthrough technologies reach patients quickly, compliantly, and with minimised risk.

CS LifeSciences’ MD Edwin Lindsay will be attending HLTH so please reach out if you’d like a meeting to discuss your requirements.

AI Medical Devices Face an Uneven Playing Field

An AI-enabled medical device that clears in the US in a matter of months may spend years navigating EU conformity assessments. Meanwhile, the UK is carving out its own path somewhere in between. Understanding these regulatory differences isn’t optional anymore for AI; it is now essential.

For all jurisdictions, regulatory compliance for AI-enabled medical devices rests on three essential pillars, each addressing a critical aspect of safety, performance, and trust:

• Core Medical Device Regulations, defining classification, safety and performance, clinical evidence;
• AI-Specific Obligations, like data governance, transparency, bias, human oversight; and
• Cybersecurity, data privacy and post-market monitoring for safety and performance.

Although the fundamental regulatory principles are broadly similar, each jurisdiction has its own approach to applying them. In this article, we will explore the differences between the UK, EU and US in regulating AI-enabled medical devices and provide actionable insights on how to achieve compliance effectively.

AI-enabled Medical Devices Obligations Across US, EU, and UK

In the US, the FDA has been proactively developing guidance documents for medical device developers. In particular, the FDA introduced the concept of a Predetermined Change Control Plan (PCCP) to address FDA’s traditional paradigm of medical device regulation that was not conducive to adaptive artificial intelligence and machine learning technologies. FDA’s PCCP guidance recommends that a PCCP describe the planned device modifications; the associated methodology to develop, validate, and implement those modifications; and an assessment of the impact of those modifications. FDA encourages developers to engage with them via the Q-Submission pathway to discuss any PCCP proposals.

For the EU, in addition to the EU MDR (Medical Devices Regulation) and IVDR (In Vitro Diagnostic Medical Devices Regulation), the EU AI Act establishes cross-sector obligations for high-risk AI, which includes most AI medical devices. The AI Act details the horizontal obligations for developers, that are intended to overlay the EU MDR / IVDR and requires developers to comply with regulatory requirements for data governance, risk management, robustness, transparency, and human oversight of an AI system. The AI Act entered into force on 1^st August 2024 and its rules will be applied in phases. Broader provisions and any prohibitions have been in force since early 2025, with most of the AI regulations to be applicable by 2^nd August 2026. Targeted requirements for high-risk AI systems will be in force a year later.

The UK currently does not have any formal AI-specific regulations, but the MHRA is crafting policies that focus on a pro-innovation, principles-based approach and has established itself as a leading regulator in this space. Notably, as part of MHRA’s regulatory reform program, the regulators are revamping the UK Medical Device Regulations (MDR) and will be including provisions for AI-enabled medical devices. MHRA has also published a roadmap for the Software and AI as a Medical Device Change Programme, where they will converge on a PCCP-esque change control system. MHRA’s goal is to reduce friction amongst the different jurisdictions and prioritise strengthening of international convergence and consensus on software and AI medical devices.

From Rules to Reality

AI-specific obligations might be at the forefront of most developers’ minds, but it is important to not lose sight of the broader regulatory landscape, including core medical device regulations, cybersecurity and data privacy requirements.

Successfully balancing the three compliance pillars requires recognising where regulations converge and applying those overlaps strategically. For instance:

• Internationally recognised standards such as ISO 14971 (risk management), IEC 62304 (software lifecycle), IEC 81001-5-1 (secure lifecycle for health software), ISO/IEC 27001 (information security), and ISO/IEC 23894 (AI risk management) can be used to build your QMS and technical documentation to meet regulatory requirements.
• The US FDA and UK MHRA utilise IMDRF guidance documents and Good Machine Learning Practice (GMLP) principles to shape their regulatory policies, so these documents should shape the design and development processes.
• A single, comprehensive technical file can be designed to meet FDA, EU MDR / IVDR, and UK MDR submission requirements, with AI Act obligations woven into the structure.
• Clinical evaluation that includes use of i) representative datasets, ii) clinically meaningful end points, and iii) sub-group analyses to demonstrate safety and effectiveness across diverse populations, can increase regulator confidence in your AI-enabled medical device.
• A robust cyber security and privacy program, aligned with international standards and best practices, can and should be implemented to protect sensitive information, maintain system integrity, and support regulatory confidence in your AI-enabled medical device.

Key Takeaway

AI-enabled medical devices must meet complex regulations, but understanding the regulatory landscape makes compliance manageable. Knowing how the US, EU, and UK differ lets developers navigate these rules confidently and bring safer, more reliable products to market.

Why Partner With CS LifeSciences?

With a proven track record in regulatory submissions and technical consultancy, CS LifeSciences offers a unique, end-to-end solution. From regulatory strategy and technical file preparation to post-market support, CS accelerate your journey from innovation to commercial success.

Ready to unlock new markets for your AI-enabled medical device?
Contact the team at CS LifeSciences today and let our experts guide you through global AI regulation – so you can focus on delivering life-changing diagnostics to patients worldwide.

Abingdon Health’s team has over 20 years’ experience in the lateral flow market and provides full service CDMO and CRO services all under one roof, including Development, Scale-Up & Manufacturing, Regulatory and Performance Evaluation, ensuring seamless and parallel workstreams saving you time and money. If you would like to discuss any specific requirements don’t hesitate to contact Abingdon’s highly experienced team.