EU Trends and Developments Contributed by: Hans-Patrick Schroeder, Kristina Weiler, Laura Knoke, Anita Bell and Rixa Kuhmann, Freshfields
tors must check labelling, with both importers and distributors required to alert manufacturers and mar - ket surveillance authorities if they become aware of a significant cybersecurity risk. Vulnerability and incident reporting obligations apply from 11 September 2026, with full requirements for new products applying from 11 December 2027. Again, non-compliance with the CRA’s essential cyber - security requirements does more than risk regulatory sanction – it can directly inform a court’s assessment of whether a connected product was defective under the PLD. The Machinery Regulation: safety obligations for autonomous machines The Machinery Regulation replaces the former Machin - ery Directive and applies from 20 January 2027. It modernises safety requirements for machinery and related products and, critically, recognises software (including AI software) explicitly as a potential safety component. The Regulation introduces specific obligations to address the realities of AI-driven and autonomous machinery. Machines must be designed so that con - nections to other devices do not create hazardous situations and safety-critical hardware, software and data must be protected against accidental or inten - tional corruption (Annex III). Manufacturers of machin - ery with self-evolving behaviour must ensure that safety-relevant decision-making processes are logged and that human intervention remains possible at all times. High-risk AI systems used as safety compo - nents are subject to mandatory third-party conformity assessments. The AI Act: safety obligations for high-risk AI systems and general-purpose AI models Finally, the AI Act establishes a risk-based framework for AI systems and general-purpose AI models, with the most stringent obligations applying to providers of high-risk AI systems – those used in safety-critical contexts such as medical devices or critical infrastruc - ture, for example. These obligations are designed to ensure that AI systems are safe, transparent, trace - able and subject to human oversight throughout their lifecycle. Thus, the AI Act also contains a set of safety
obligations specifically for High-Risk AI systems, as well as for General-Purpose AI models, including mandated standards covering: • the accuracy, robustness and cybersecurity of the AI product; • AI product’s transparency to deployers/users; and • the quality of data governance. Previously, AI systems functioning as safety compo - nents of machinery (as per the Machinery Regulation) were automatically classified as high-risk AI systems under the AI Act. However, the Digital Omnibus on AI significantly redraws the relationship between the AI Act and the Machinery Regulation. While political agreement was reached in April 2026, formal adoption by the European Parliament is anticipated at the June 2026 plenary session, paving the way for publication in the EU Official Journal in late June or early July 2026. Under this agreement, AI systems integrated into machinery will no longer be directly subject to the full obligations for high-risk AI systems under the AI Act. The Machinery Regulation instead becomes the primary compliance framework. The level of protec - tion sought remains consistent with the AI Act – the intent is not to lower safety standards but to put AI- enabled machinery under a single, integrated com - pliance framework rather than two parallel high-risk AI regimes. That said, any non-compliance with the safety requirements for high-risk AI products, whether under the AI Act or the Machinery Regulation, directly informs a court’s assessment of defectiveness under the PLD. This means that compliance with product- inherent safety obligations for AI systems becomes an integral part of businesses’ product liability risk management. Conclusion The reforms described represent the most significant realignment of EU product liability and product safety law in decades. The revised PLD redraws the rules for no-fault liability: • expanding the scope; • broadening the pool of defendants; • easing the evidentiary burden for claimants; and
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