The New EU Product Liability Directive: 10 Things to Know

This blog was originally posted on 9th September, 2026. Further regulatory developments may have occurred after publication. To keep up-to-date with the latest compliance news, sign up to our newsletter.

AUTHORED BY JOYCE COSTELLO, SENIOR REGULATORY COMPLIANCE SPECIALIST, Adherent

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The new EU product liability rules significantly expand the products, damage and parties covered by the liability regime, including software and AI. From 8 December 2026, manufacturers and modifiers will face longer potential exposure, broader tests for defectiveness, increased disclosure obligations and circumstances in which claimants’ burden of proof may be eased.

Introduction

New EU product liability rules, substantially overhauling the common rules which have been in place for almost 40 years, will apply to products placed on the market from 8 December 2026. 

The new measure, Directive (EU) 2024/2853, responds to societal developments related to new technologies, including artificial intelligence (AI), new circular economy business models and new global supply chains.

A single-word description of the transition from the regime under Directive 85/374/EEC to Directive 2024/2853 is expansion – expanded range of products in scope, an expanded conception of damage, and expanded ability for consumers to bring claims against manufacturers.

To date, a significant number of Member States have not yet published implementing measures. Directive (EU) 2024/2853 is a maximum harmonisation Directive (Article 3), so Member States are generally prohibited from maintaining or introducing rules that depart from it, unless they are given express discretion to do so. For example, they may exclude the ‘development risks’ defence – potentially leading to a more business-friendly liability regime in some Member States than in others. Pending transpositions by all Member States, the overall picture remains to be drawn.

For now, Adherent has distilled into ten points the key aspects that all product manufacturers and modifiers should know about these new rules ahead of their commencement in December:

1. “Product” expressly includes software and AI

Product-liability exposure is no longer principally about physical goods and property. Under Directive 2024/2853, “products” include software like operating systems, applications, updates and AI systems. In addition, any connected or embedded services required for the product to work are included if the manufacturer controls them. 

2. Categories of compensable damage include medically recognised psychological harm and data destruction or corruption

The 1985 Directive is limited to traditional notions of damage, like death or personal injury and damage to tangible property. 

Personal injury under Directive (EU) 2024/2853 includes medically-recognised and medically-certified damage to psychological health that affects the victim’s general state of health and which could require therapy or medical treatment. Non-physical harms occasioned by AI-enabled and digital products can therefore be captured by the liability net and compensated.

The right to compensation also exists when the defective product causes the destruction or corruption of data not used for professional purposes. Because consumers increasingly hold things of value in digital form, the Directive recognises certain damage to data as its own independent category of compensable damage. For example, a defective smart-home device corrupting locally stored photographs or videos or a storage device destroying a consumer’s files could (all other conditions being met) constitute recoverable damage.

3. Liability can be allocated to parties who substantially modify a product 

Original manufacturers making substantial modifications to products will be liable for any harm arising from defects in those products, and won’t be able to evade liability by arguing that the defect arose after it originally placed the product on the market or put it into service.

However, where it can be shown that the modification was not within the control of the original manufacturer, the Directive creates the possibility of holding the person that made the substantial modification liable as a manufacturer of the modified product, where the defect relates to a part of the product affected by the modification.

Software updates, upgrades and AI learning

Manufacturers of smart products should be aware that the same principles of substantial modification apply to products allowing for modifications through changes to software, including upgrades. Where a substantial modification is made through a software update or upgrade, or due to the continuous learning of an AI system, the substantially-modified product should be considered to be made available on the market or put into service at the time the modification is actually made.

Such software updates and upgrades should be considered to be within the manufacturer’s control where they are integrated, inter-connected or supplied by the manufacturer itself or where the manufacturer authorises or consents to their supply by a third party. Thus, the manufacturer remains responsible for the defect.

4. Directive guarantees claimants access to an EU-based defendant, even when the manufacturer is located outside the Union

This is a particularly significant change for importers, authorised representatives, fulfilment providers and businesses selling through online platforms.

This ensures that, where the manufacturer is outside the EU, the claimant is not left without a potentially reachable defendant merely because of this fact. It does not imply the automatic liability of every EU intermediary, rather a hierarchy of potentially liable parties applies:

Situation	Potential EU-Based Defendant
The non-EU manufacturer has appointed an EU authorised representative	Authorised representative
A non-EU product or component is imported into the Union	EU importer
There is neither an EU importer nor an EU authorised representative	Fulfilment service provider established in the Union
None of the relevant operators can be identified	Distributor if it does not identify the relevant operator within one month following the injured party’s request

5. Extended 25-year expiry period applies for latent personal injuries

From 8 December, in circumstances where personal injury symptoms are slow to emerge, injured persons have a 25-year period within which to initiate proceedings. This will ensure that consumers are not barred from seeking compensation in complex cases where the injury remains latent, by holding them to the 10-year general rule. 

For product manufacturers, it means that product-liability exposure can remain alive for an additional 15 years where an injury takes a long time to manifest.

6. Member States can provide for compensation for non-material losses 

Member States are only obligated to ensure compensation for non-material losses (pain and suffering, grief, or distress) if and to the extent their own domestic laws already provide for (or allow) non-material damages for those types of harm. The losses must flow from the specific types of damage listed in the Directive – death/personal injury, property damage within scope or non‑professional data destruction/corruption. By deferring to national law, Directive 2024/2853 maintains divergent national approaches to non-material loss.

7. New development risks defence can be excluded by Member States

Notwithstanding its maximum harmonisation status, Member States are given discretion to exclude or limit the ‘development risk’ defence. 

Member States can, by way of derogation from Article 11(1)(e), maintain existing measures to the effect that economic operators will be liable even if they prove that the state of scientific and technical knowledge at the time when the product was placed on the market, put into service or in the period in which the product was within the manufacturer’s control was not such that the defectiveness could be discovered. Any derogation must be limited to specific categories of products, justified by public interest objectives and proportionate.

Finland currently does not intend to include the development risk defence, so a producer will not escape liability there by showing that the defect was undiscoverable given the state of scientific and technical knowledge at the relevant time. However in neighbouring Sweden, the business-friendly option permitted by Article 18 of the Directive is retained, so already a difference in liability risk is apparent.

8. New test for defectiveness

The baseline test remains the same: a product is considered defective if it does not provide the safety that a person is entitled to expect. Directive (EU) 2024/2853 does however broaden and modernise the circumstances expressly relevant to determining whether a product is defective.

The new Directive treats products as evolving and considers software updates, ongoing AI learning, connections to other IoT devices and systems and how well the product is protected against cybersecurity risks as part of the safety judgment.

The result is that manufacturer responsibility will last long after the sale, since a product that was completely safe on day one can become legally “defective” months or years later, so manufacturers must design products to withstand not just intended use but also reasonably foreseeable misuse.

9. Disclosure of evidence

A claimant who puts forward sufficient facts and evidence to make the compensation claim plausible can require the defendant to disclose relevant evidence in its possession, subject to necessity and proportionality safeguards (and protection for confidential information/trade secrets). 

This is a major practical change for manufacturers. Technical files, testing, risk assessments, design decisions and potentially software-related evidence may become important later for defending civil litigation. 

This obligation seeks to redress the information imbalance between claimants and producers, who often control the evidence needed to prove defectiveness and causation. A defendant’s failure to comply with a disclosure obligation may result in a rebuttable presumption that the product is defective (the defendant may still adduce evidence to show that the product was not defective).

10. Burden of proof may be eased in case of a complex product

Where a product’s technical or scientific complexity makes it excessively difficult for an injured claimant to prove defect or causation, national courts must apply a rebuttable presumption of defect, causation, or both. The claimant need only show, based on available evidence, that the product was likely defective or likely caused the damage, and the manufacturer effectively bears the burden of showing that the product was not defective (and/or did not cause the damage).

Conclusion

As the December 2026 deadline approaches, the transition to this new liability framework marks a fundamental shift for manufacturers. With an expanded scope covering software and AI, coupled with extended limitation periods and eased burdens of proof, manufacturers must start moving towards proactive risk management to effectively mitigate the risks posed by this modernised directive.

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