The new EU Product Liability Directive (2024/2853) (new PLD) came into force on 8 December 2024, marking the most significant overhaul of Europe’s product liability regime in nearly four decades.
This article outlines the key changes introduced by the new PLD. It explores the expanded scope of liability and the broader pool of potentially liable parties, as well as the new rules on the burden of proof and disclosure of evidence.
Why is this important?
The new Product Liability Directive will completely replace the old Product Liability Directive (85/374/EEC) from 1985. It introduces a new set of product liability rules that Member States must implement in their national legislation.
The new PLD aims to modernise product liability rules and strengthen consumer protection by:
- Adapting product liability to the digital age. The new PLD directly responds to technological advances and the growing prevalence of digital and AI-driven innovations, as well as new circular economic business models and the complexity of global supply chains. It intends to ensure that claimants have the same level of protection, regardless of the technology involved.
- Making it easier for consumers to obtain compensation. The EU legislator found that, under the previous PLD, injured persons faced difficulties in obtaining compensation in the event of harm caused by defective products. The new PLD aims to reduce these difficulties.
To this end, the new PLD considerably expands the scope of liability for companies placing products on the EU market. As before, product liability is strict liability, meaning that consumers do not have to prove a company's negligence or fault.
What’s new?
Designed to reflect the realities of today’s digital and interconnected economy, the new PLD broadens the definition of a 'product' to include software and digital products. It significantly increases the liability exposure not only of manufacturers and importers, but also of additional actors involved in the selling or distribution of products. The new PLD also lowers the threshold for consumers to bring product liability claims, particularly in complex cases. It introduces a new procedural tool that enables the courts to compel defendants to disclose any relevant evidence at their disposal.
In detail:
Extended liability for new technologies
The new PLD explicitly considers software – both embedded software (eg in a radiotherapy device) and standalone software (eg digital health monitoring software that uses the sensors of a physical product to collect data) – as well as AI-integrated products a 'product' subject to strict liability. This extended scope of liability includes medical device firmware and healthtech apps (eg AI-enabled diagnostic tools or clinical decision support systems).
Importantly, under the new PLD, liability can not only be triggered by defects of the original product, but also by inadequate software updates or poor cybersecurity protections.
The new definition of 'defectiveness' also takes product safety requirements into even greater account. This includes mandatory cybersecurity obligations, such as those introduced by the Cyber Resilience Act, as well as safety standards under the AI Act. Non-compliance with these requirements, as well as regulatory interventions such as a product recall, can be taken into account by the courts when determining whether a product is defective. Consequently, liability under the new PLD now extends beyond the point of sale to encompass the product’s entire lifecycle – including post-market updates and the functionality of digital elements linked to physical products.
More potential defendants
Under the new PLD, strict liability is no longer limited to manufacturers and importers. It also extends to:
- Authorised representatives of the manufacturer, including those placing non-EU products on the market.
- Fulfilment service providers, responsible for logistics, when manufacturers or importers are not established in the EU.
- Distributors and online marketplace operators, in limited circumstances – particularly if the actual manufacturer or other responsible economic operator is unavailable or non-compliant.
- Entities that substantially modify a product, including software updates or AI models, which effectively become new 'manufacturers' for liability purposes.
This extension of liability to other economic operators aims to ensure that injured persons have an enforceable claim for compensation where a product’s manufacturer is based outside the EU. It also increases accountability within complex supply chains.
Burden of proof
One of the key objectives of the new PLD is to facilitate access to justice by reducing the evidentiary hurdles for injured parties. To this end, the new PLD eases the burden of proof for claimants by establishing a presumption of defectiveness and a causal link in complex cases where:
- proof is 'excessively difficult' for the claimant due to the technical or scientific complexity of the product
- a product defect and/or causality is at least 'likely'.
This new presumption is particularly important for innovative medical devices, which the EU legislator expressly mentions as an example (see recital 48 of the new PLD).
A defect is also presumed if the product does not comply with mandatory product safety requirements under union or national law that are intended to protect against the risk of the damage suffered by the claimant. The European Commission emphasised that this does not reverse the burden of proof, and it remains the claimant’s responsibility to prove their case. In practice, however, we can see many cases where technical difficulties could result in the defendant having to rebut the presumption and prove that the product was not defective and/or did not cause the alleged harm.
Furthermore, additional rebuttable presumptions may arise if the defendant fails to disclose relevant evidence, or if the malfunction becomes apparent during normal use.
Disclosure of evidence
Under the new PLD, national courts are empowered to order the disclosure of relevant evidence that is at the defendant’s disposal, provided that the injured party has presented a sufficiently substantiated claim for damages.
This new procedural tool significantly alters the litigation landscape by making it easier for claimants to obtain internal documents and technical data from defendants, thereby lowering the evidentiary burden traditionally faced in complex product liability cases (particularly those involving medically or technologically complex products). This marks a significant procedural change in many European jurisdictions, which currently have no disclosure mechanisms in place. Accordingly, legislative and/or procedural adaptations may be required at a national level to give full effect to this provision.
Importantly, the new PLD requires courts to take appropriate measures to protect the confidentiality of any trade secrets or other sensitive business information disclosed in the proceedings. However, it does not set out a harmonised procedure for ensuring such protection. This leaves it to Member States to implement suitable safeguards in accordance with union law, including Regulation (EU) 2016/943 on the protection of trade secrets.
Further adaptations of the product liability regime to the digital age
Further amendments regarding digital products include that claimants can sue for wider damages, including the destruction or corruption of data. In addition, the new PLD removes existing claim thresholds (eg the EUR500 minimum for property damage) and maximum caps. It also limits certain existing liability exemptions. Of particular importance to companies operating in the life sciences sector is the extension of the expiry period for latent damage claims from 10 to 25 years.
What to look out for
The new PLD marks a significant overhaul of the EU’s strict liability regime by introducing a more claimant-friendly framework that lowers evidentiary barriers. For companies operating in the life sciences sector, the implications are significant, as it will become easier for consumers to claim compensation for defective products. The new PLD is likely to increase litigation exposure for life sciences companies, particularly in cases of technical or scientific complexity, where it is difficult for injured parties to prove a product defect and/or establish a causal link between a product and alleged harm. While the European Commission maintains that the burden of proof has not been reversed, it remains to be seen how the courts will apply the new evidentiary presumptions and whether this will significantly ease the burden of proof and increase product liability risks for companies placing products on the EU market.
Member States now have until 9 December 2026 to implement the new PLD into national law. The new rules will apply to products placed on the market after this date. The previous Product Liability Directive (85/374/EEC) will continue to govern the liability of products that are already on the market by that date.
Following implementation, courts across the EU will need to interpret and apply these new rules, and significant divergence may emerge depending on national procedural frameworks, particularly in jurisdictions that are unfamiliar with “discovery-style” evidence disclosure. Therefore, the ultimate impact on liability exposure will depend not only on the text of the implementing legislation in the Member States, but also on how national courts will implement and interpret its provisions.
We advise companies to use the transition period to prepare for compliance with the new product liability regime. Please contact our authors for further information using the links in their profiles. For an overview of what to expect and how to prepare, please also see here.
