UK Law and Practice Contributed by: Lisa Lunt and Sarah Samuel, Fletchers Solicitors
than through wholesale reform. In practice, however, regulatory expectations and enforcement priorities are increasingly shaped by technological change, digitisa - tion of products and supply chains, and comparative developments in other jurisdictions, most notably the EU. Divergence From EU Developments A key external influence is the EU’s revised Product Liability Directive (EU) 2024/2853. Although the Direc - tive does not apply in the UK, it is highly relevant in practice because UK-based manufacturers, importers and distributors placing products on the EU market will fall within its scope, and its approach is likely to inform future UK policy debate. Notable features of the EU regime include: • an expanded concept of “product”, encompassing standalone software, software embedded in goods, and post-market updates or upgrades; • a broader range of potentially liable defendants, including online marketplaces and fulfilment opera - tors; • claimant-friendly evidential mechanisms, including rebuttable presumptions of defect and causation in technically complex cases; and • extended longstop limitation periods in latent dam - age cases. While these changes have no direct effect in the UK, they are increasingly influencing risk assessments, compliance strategies and litigation planning for busi - nesses operating across multiple jurisdictions. Expansion of Liability Concepts to Digital Products, Software and AI Traditional product liability concepts in England and Wales are being tested and incrementally adapted to address digital and software-enabled products. Although the CPA does not expressly define software as a product, the prevailing view remains that software may fall within scope in appropriate circumstances, particularly where it forms part of a tangible product or affects its safety performance. Artificial intelligence represents a further area of regu - latory and litigation interest. The UK has adopted a
comparatively flexible, principles-based regulatory approach focused on innovation, in contrast with the EU’s prescriptive AI Act. In practice, legal risk is cur - rently mediated through: • sector-specific regulators (for example, the MHRA in relation to AI-enabled medical devices); and • existing product safety obligations relating to risk assessment, monitoring and corrective action. Questions around defect, foreseeability and control in adaptive or learning systems remain legally unre - solved and are expected to feature more prominently in future litigation. Increased Regulatory Focus on Post-Market Obligations Another clear trend is the growing emphasis on post- market surveillance and life cycle safety obligations. Regulators increasingly expect manufacturers and other economic operators to: • actively monitor product performance and emerg - ing safety signals; • respond swiftly to risk trends through warnings, withdrawals or recalls; and • maintain alignment between post-market data, technical documentation and risk assessments. This reflects a shift away from viewing compliance as a one-off pre-market exercise, and towards ongoing responsibility throughout a product’s lifespan. Procedural and Evidential Developments Several procedural themes continue to attract atten - tion in product liability litigation: • Expert-Driven Disputes: Courts are increasingly required to manage complex, expert-heavy cases, particularly in pharmaceuticals, medical devices and technology-focused claims. • Collective Proceedings: Group litigation, represent - ative claims and co-ordinated case management orders are being used more frequently in large- scale product disputes, especially in consumer- facing sectors. • Regulatory Co-Ordination: There is growing interaction between regulators, including Trad -
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