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Revised EU product liability regime expands to AI software providers

Technology companies offering products and services in the EU will need to prepare for significant changes to be brought in by the new Product Liability Directive which has broadened the definition of a ‘product’ to include software, with artificial intelligence (AI) systems being an example.

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Out-Law /
Your Daily Need-To-Know

OUT-LAW ANALYSIS

7 min. read

Revised EU product liability regime expands to AI software providers

20 Dec 2024, 3:40 pm

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Follow Artificial intelligence

Technology companies offering products and services in the EU will need to prepare for significant changes to be brought in by the new Product Liability Directive which has broadened the definition of a ‘product’ to include software, with artificial intelligence (AI) systems being an example.

The EU’s new
Product Liability Directive
(PLD) came into force on 8 December 2024, beginning a two-year countdown before the new framework expands significantly to adapt for an increasingly digital economy.

One of the headline changes introduced by the PLD is to expand the definition of a ‘product’ to include software. Although the PLD has left the definition of software open-ended to account for future technological developments, Recital 13 of the PLD gives operating systems, firmware, computer programs, applications or AI systems as examples of ‘software’. This change is designed to help consumers bring damages claims when something goes wrong with the operation of an AI system.

The new product liability regime comes shortly after
the EU AI Act
entered into force on 1 August, and further demonstrates the need for organisations intending to deploy or use AI in the EU to understand the evolving regulatory landscape in the area. This is an area we expect to see more developments in as the EU continues in its aim to be the leading force in AI regulation. More developments in this area have already been in the pipeline such as the AI Liability Directive. The impact assessment for the proposed AI Liability Directive was published on 19th September, and is expected to see further development throughout 2025.

While there is a two-year implementation period for member states to transpose the PLD into national law, relevant organisations, particularly technology companies, should conduct a thorough review of EU and national product safety laws to familiarise themselves with the rules that their products will now fall under. A gap analysis should then be conducted to address any areas in which their products may not meet these standards so that these issues can be addressed.

As a lack of software updates leading to injury can now also lead to a claim for compensation, a review to see if any old products have not received required software updates should also be conducted. Manufacturers should also be mindful of and introduce processes for possible disclosure exercises.

Timeframe for implementation

EU member states have until 9 December 2026 to transpose the PLD into national law. The new PLD will replace the
existing Product Liability Directive
, known as 85/374/EEC, which standardised member states’ product liability laws. The current directive will be repealed with effect from 9 December 2026, however, it shall continue to apply to products placed on the market or put into service before that date.

Although the new directive only applies to products placed on the market or put into operation after the expiration of the implementation period, manufacturers should begin preparing for these significant changes as soon as possible, particularly manufacturers of AI systems.

Expanded scope

Under the PLD, liability falls on a wide range of “economic operators”, which include the manufacturer of the product or component, the provider of a digital service that is integrated into the product, the authorised representative, the importer and any fulfilment service provider - such as warehousing, packaging, parcel delivery services or the distributor. In addition, anyone who significantly modifies a product outside the manufacturer's control and then makes it available on the market or puts it into operation will be considered a manufacturer. Where two or more are liable for the same damage under the PLD, they can be held liable jointly and severally.

“Making available on the market” includes supplying a product free of charge as well as in return for payment.

Implications for software and AI products

The expanded definition of ‘product’, which brings software, such as AI systems, into the scope of the product liability regime is one of the most important features of the new PLD. It is a significant development for those engaging in the AI space within the region, whether they are developing the technology themselves or importing it from overseas. The fact that software now falls under the same regime that has governed physical products in the EU since 1985 further cements the need for these systems to be developed with safety in mind from the beginning, including concerns such as the safety of user data.

This expansion of the definition of a product is accompanied by an expansion of the concept of a ‘defect’. Most notably, its meaning has been widened to include any issues that arise from software updates. Recital 32 of the PLD states that a product can also be found to be defective due to cybersecurity vulnerabilities, and that manufacturers who design products with the ability to develop unexpected behaviour will remain liable for any damage caused by that behaviour. This is particularly important for developers of AI systems as it means that an AI system acting in an unpredictable manner will not be a defence in the event of any damage being caused.

The principle of strict liability is now extended to digital products as well as material goods. This means that a person can claim compensation from manufacturers of defective products or defective components placed on the EU market or put into service for damages caused by these products.

However, the PLD does not apply to free and open-source software that is developed or supplied outside the course of a commercial activity.

Damages to personal data recoverable

The scope of damages has been extended under the PLD to include medically recognised damage to psychological health as well as the corruption or destruction of data. The inclusion of recovery for corruption or destruction of data only applies to data used in a personal context. This is in line with the EU’s approach under the previous directive in that damage to any physical property used for purely professional purposes were non-recoverable.

Applicability to non-EU products

The PLD does not only expand existing terms but also introduces new protections to consumers in the EU market. One such protection is making sure that consumers are compensated for damage caused by products manufactured outside of the EU by making the importer or the manufacturer’s representative liable for any potential damage caused. This is particularly important in the AI space with so many AI systems being developed in jurisdictions such as the US.

Disclosure of evidence

As a claimant often has no insight into the functioning of a product, in particular AI systems, it is difficult for the claimant to prove the product’s defects and show a causal link for any damage. To address this, the PLD introduces a new disclosure regime including for representative actions. Claimants only need to provide “facts and evidence to support the plausibility of the claim for compensation” to obtain disclosure from the manufacturer. However, this is limited to what is “necessary and proportionate” and will take into account the protection of confidential information and trade secrets.

Burden of proof

The PLD offers new protection for claimants by reversing the burden of proof necessary to avail of those protections in certain circumstances. This change is due to criticism under the old regime that for some products, it was unnecessarily difficult to prove a product was defective due to the complex nature of the product itself.

To combat this, article 10 of the PLD states that the defectiveness of a product will now be presumed in three circumstances. It will apply when:

the defendant fails to disclose relevant evidence;

the claimant can demonstrate that the product does not comply with mandatory product safety requirements laid down in EU or national law; or

the claimant can show that the damage was caused by an obvious malfunction of the product during reasonably foreseeable use or under ordinary circumstances.

Expiry period

The relevant timeline during which a claimant must make a claim has also been extended by the PLD. Under the old rules, the rights conferred upon an injured claimant expire after a ‘long stop’ period of 10 years unless they institute proceedings within that time. This rule has seen two significant changes.

The first is that this 10-year period now resets in the event that a product sees substantial modification, with the clock beginning again when the product is put on the market following its significant modification.

The second is that this period is extended to 25 years in the event that the claimant was not able to initiate proceedings during the 10-year period due to the latent nature of the personal injury.

Defences

The PLD sets out similar defences to the old regime, including if the defect causing the damage did not exist at the time the product was placed on the market or put into service, or if the scientific and technical knowledge of the time was not such that the defectiveness could be discovered. However, the former defence will not apply in certain circumstances, for example, where the defect is due to a lack of software updates or upgrades necessary to maintain safety or due to a substantial modification of the product, as all of which are within the manufacturer’s control.

Software and AI manufacturers should be particularly mindful as they could incur liability for defects caused by an update or upgrade installed after the product was placed on the market, or due to the lack of implementing a necessary update.

The PLD allows EU member states to derogate from the scientific and technical knowledge defence. Each state is allowed to maintain existing rules or introducing new measures, so that manufacturers are liable even if they prove that the defectiveness could not be discovered due to the state of knowledge at the time the product was placed on the market or put into service.

Co-written by Lynsey Burke, Isabel Humburg and Aiden Daly of Pinsent Masons.

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Written by

Lynsey Burke

Senior Associate

+353 87 164 2822

[email protected]

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1. The revised Product Liability Directive (EU) 2024/2853 (in force December 8/9, 2024; transposition deadline December 9, 2026) expressly brings software and AI systems within strict product liability and, critically, introduces rebuttable presumptions of defectiveness and causation that shift the burden toward the manufacturer where the claimant faces excessive technical/scientific complexity.
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