Life sciences - market insights Q3/Q4 2024

UK medical device regulation

In January 2024, the Medicines Healthcare products Regulatory Agency’s (MHRA) published its roadmap for a new medical devices regulatory framework which aims to prioritise patient safety and facilitate quick access to new medical device technologies. The core regulatory framework is intended to come into force in 2025. There will be a phased approach to implementation to support ‘system readiness’ and minimise the risk of supply chain disruption for UK patients.

Over the coming months, stakeholders should have greater clarity as to the extent to which the UK’s new regime will be aligned with the EU framework. Whilst alignment with the EU framework was once the preferred approach, extensive delays arising from the transition to the new EU Medical Device Regulation (MDR) and EU In Vitro Diagnostics Regulation have led to a bottleneck of certification approvals and knock-on supply shortages. Notwithstanding the challenges caused by Brexit, the UK may become the preferred market of choice for medical device manufacturers, particularly start-ups, who might be more attracted to its streamlined framework and support for innovation.

The roadmap is complemented by the MHRA’s draft proposal for a framework for the recognition of international regulators’ approvals of medical devices, including those from the EU, the US, Australia and Canada, to ensure patients have safe access to innovative medical devices. The proposal also aims to reduce the duplication of assessments by comparable regulators, enabling resource to be focused on innovative products. The list of comparable regulator countries remains under the MHRA’s review.

The EU Artificial Intelligence Act (AI Act) and AI Liability Directive

The EU’s AI Act came into force on 1 August 2024 and introduced the world’s first set of comprehensive rules to manage and regulate the risks posed by AI. The Act aims to fill some of the gaps left by existing sector specific regulation, such as the EU MDR. It adopts a risk-based approach so that the ‘riskiest’ forms of AI, such as AI-enabled precision medicine tools, are subject to the most stringent obligations, including human oversight and continued maintenance.

The proposed AI Liability Directive, which will sit alongside the AI Act, will enable consumers who are harmed by AI to sue the providers for damages arising from AI failures or non-compliance with the AI Act. This will include patients who are treated by or use AI-enabled medical technologies. The MedTech industry could be disproportionately impacted by this new regime given the extent to which AI is used in products that will be classified as high risk.  

We have also identified the AI Act as a key update in Cyber and Product liability. The AI Liability Directive is also discussed in Product liability.

MHRA’s AI strategy

Further to the previous government’s light touch, principles based, pro-innovation approach to AI regulation, the MHRA’s AI strategy, published on 30 April 2024, addresses the risks and opportunities of AI from the MHRA’s perspective.

Artificial intelligence that is adopted for use as a medical device (AIaMD) must conform to the requirements of the UK Medical Device Regulations 2002 across the product’s lifecycle, mandating post-market surveillance and clinical feedback activities to mitigate risk and address the safety and performance of devices. The MHRA advocates a proportionate approach to AIaMD regulation and intends to adopt principles, supplemented by guidance (including on cybersecurity, due for publication by 2025) to safeguard innovation whilst ensuring patient safety.

Following the publication of its AI strategy and as foreshadowed in its roadmap, on 9 May 2024, the MHRA launched AI Airlock, a regulatory sandbox for AIaMD. The AI Airlock, which will initially involve the support of 4 - 6 real-world projects, will help the MHRA identify and address the challenges for regulating AIaMDs with a view to facilitating their safe development and deployment in the future.

Perfluoroalkyl and polyfluoroalkyl (PFAS) substances

Growing concerns about the potential environmental and health risks linked to perfluoroalkyl and polyfluoroalkyl (PFAS) substances has led to an increase in lawsuits globally, particularly in the US where thousands of PFAS-related civil lawsuits have been filed. Many medical device manufacturers use water insoluble PFAS-type coatings, such as fluoropolymers, across a range of products and in packaging.

With five EU member states seeking to introduce an EU-wide ban on all chemicals in the PFAS group, and with the UK also looking at potential restrictions on the use of PFAS in certain products, medical device manufacturers will need to start considering alternative, “greener” chemicals to use in their products.

We have also identified PFAS chemicals as a key update in the Complex casualty: coverage disputes section.