The new Product Liability Directive: three life sciences priorities before the 2026 deadline

The new Product Liability Directive (EU) 2024/2853 (“PLD”) replaces a regime that has governed product liability since 1985. The directive entered into force in December 2024, and Member States must transpose it by this December. The new rules will apply to products placed on the market or put into service after 9 December 2026, so much of what companies design and release this year will be among the first to fall under the PLD application.

With the transposition deadline now months away, the important question for life sciences companies is which changes call for decisions and preparation now. Three stand out.

Software and AI are products in their own right: PLD brings software within the definition of a product, including standalone applications, AI systems and software updates. A manufacturer can be liable for a defect introduced by an update, or by the failure to provide an update needed to keep a product safe (including safety-related cybersecurity requirements), where that update is within its control. For life sciences companies this reaches well beyond physical hardware: diagnostic algorithms, digital therapeutics, connected drug-delivery systems and clinical decision-support tools all are within scope. In practice, an AI-based diagnostic tool with a decreased accuracy after a model update could expose its manufacturer to liability, even though the ‘main’ product never changed.

Claimants will find it easier to prove a defect: National courts can presume that a product was defective, or that a defect caused the damage, where the claimant faces excessive difficulty in proving this because of the technical or scientific complexity of the product. Recital 48 names innovative medical devices as a leading example, but the same logic applies to complex pharmaceuticals, biologics and AI-driven products. The effect is a real shift in litigation risk and can impact sophisticated life sciences products the most. For example, a court hearing a claim about a novel biologic could presume causation where the underlying science is too complex for the patient to prove it directly, provided the claim is otherwise plausible. It is worth noting that PLD introduces additional mechanisms that ease the burden of proof conditions for claimants, such as presumption of the defectiveness where the defendant fails to disclose relevant evidence according to the directive rules. 

Internal technical documentation may have to be disclosed: Courts will be able to order a defendant to disclose relevant evidence within its control once a claimant has presented a sufficiently plausible claim, subject to safeguards for trade secrets. Technical files, post-market surveillance data, vigilance records and design documentation, which life sciences companies have generally prepared for regulators rather than for opponents in litigation, may become discoverable. The quality and consistency of that documentation could be tested also by claimants, not only by notified bodies and competent authorities. A post-market surveillance file recording a known performance issue could be requested by a claimant to argue that a product was defective. PLD includes a limitation of this obligation to what is “necessary and proportionate”, but this may prove challenging for life sciences in practice, while the approach of courts to this issue may differ from one member state to another. 

The transposition deadline is fixed. Because the new rules attach to products placed on the market after the cut-off, decisions taken during 2026 – on product design, documentation, contracts and insurance – will shape the legal situation for a company once the regime applies and is implemented locally. 

Key Takeaways/ to-dos:

•  Map the product portfolio against the new definition of a product, with software components, embedded AI and the update lifecycle in mind. Treat 9 December 2026 as a portfolio planning date, deciding which products will be placed on the market under the new regime.
• Review technical documentation, post-market surveillance and vigilance files with civil litigation in mind, not only regulatory eye (since this material could now be disclosed to claimants).
• Monitor national transpositions - although PLD adopts full harmonisation framework (meaning stricter or more lenient rules generally cannot be implemented locally unless explicitly allowed), procedural points, such as how local courts handle disclosure orders, could still differ between member states.
• Reassess insurance cover against the updated rules and risk-exposure points.