UK Law and Practice Contributed by: Simon Antrobus KC, Mike Atkins, Elizabeth Boon, Richard Sage, David Myhill and Alex Antelme KC, Crown Office Chambers
• The definition of “product” is expanded. For the first time, it expressly includes software and services or updates/upgrades, includ - ing those provided by a third party where the manufacturer approves of that supply. • The definition of defect is materially the same as the original PLD but the new PLD provides a clearer and longer list of the range of cir - cumstances that may be taken into account. • The PLD retains a test of strict liability when considering whether a product is defective. However, and importantly (particularly in the context of the domestic law decision in Hast - ings), the new PLD makes a substantial and claimant-friendly change to the burden of proof. The new PLD makes provision for: (a) a rebuttable presumption of causation “where it has been established that the product is defective and that the damage caused is of a kind typically consistent with the defect in question” ; and (b) a rebuttable presumption of defect and/ or causation where the “claimant faces excessive difficulties, in particular due to technical or scientific complexity, in proving the defectiveness of the product or the causal link between its defective- ness and the damage, or both” and “the claimant demonstrates that it is likely that the product is defective or that there is a causal link between the defectiveness of the product and the damage, or both.” • The limitation long-stop is extended from ten to 25 years in cases of latent damage, although it remains to be seen how the Euro - pean courts will approach the issue of latent damage. These are major and important changes. What impact they will have on the approach taken by parliament in domestic law remains to be seen, but it is clear that these changes will have major
consequences for UK manufacturers selling into the EU, and for others (such as distributors) who may be potential defendants under the new PLD. In domestic law, an important change has occurred in relation to the post-market surveil - lance requirements in respect of medical devic - es. The Medical Devices (Post-market Surveil - lance requirements) (Amendment) Great Britain) Regulations 2024 will come into force on 16 June 2025 and will result in a greater burden on manufacturers of medical devices in relation to post-market surveillance activities. These regu - lations require manufacturers to maintain a post- market surveillance system for each device, to identify incidents (falling into various categories), to identify preventative and corrective actions, to monitor trends, and to ensure that the mat- ters gleaned through post-market surveillance are reflected in the technical documentation. This forms part of the MHRA’s revised road - map towards the future regulatory framework for medical devices, published on 11 December 2024. The EU has also taken the first steps in produc - ing a comprehensive regime for the regulation of artificial intelligence in the form of the EU’s Artificial Intelligence Act, which came into force on 1 August 2024 and aims to regulate AI risks across a wide range of sectors. Its aim is to reg - ulate the producers of AI systems rather than creating enforceable rights on individuals, and it classifies AI applications by reference to their risk of causing harm: • AI applications with an unacceptable risk are banned; • high-risk and general-purpose AI applications must comply with a range of requirements; • limited-risk AI applications must comply with transparency requirements; and
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