knowledge 26 June 2025 |

The New EU Product Liability Directive: Key Changes and Implications for the Life Sciences Sector

Overview

The new Product Liability Directive marks the most significant overhaul of product liability law in nearly four decades.  It will make it easier for individuals to bring claims against manufacturers, with implications for the life sciences sector. The Directive was enacted on 8 December 2024 and must be transposed by all member states by 9 December 2026.  

The original Directive, enacted in 1985, established a no-fault liability regime for defective products, allowing consumers to claim compensation for injuries without needing to prove negligence or a contractual relationship with the producer. The new Directive retains much of the original law, with significant updates to account for technological advances over the past 40 years and evolving standards of consumer protection.  It aims to address perceived shortcomings in the current regime, and particularly the difficulties encountered by injured parties in claiming compensation for damages.

The changes in the new Directive are relevant to those operating in the life sciences sector and to producers of complex products, components, raw material and related services.  

This briefing outlines the impact of the changes, and the practical steps organisations should consider to mitigate risk across different company operations, from product development, to manufacturing, to post-market safety monitoring.   

Key Changes in the New Directive

1. Expanded Definition of ‘Product’ and Liable Parties

The new Directive broadens the definition of a ‘product’ to include software (including software updates and upgrades). The Directive also expands on the concept of component as including a digital service that is integrated into, or inter-connected with, a product (a “related service”).

An example of a related service is a health monitoring service that relies on physical sensors to track a user’s activity or health metrics.  Both a producer of a product that has integrated (or authorised someone else to integrate) a related service into the product or the producer of the related service itself, may be liable if the related service is defective.

These expansions bring a wider range of entities within the ambit of the Directive, including software developers, digital health providers and other entities along the supply chain. The expansions also highlight the need for life sciences companies to adopt appropriate risk minimisation measures when incorporating digital services into their products, including in particular those that leverage AI.

2. Compensation for Psychological Damage

The new Directive expressly recognises psychological injury as a compensable harm, which has the potential to broaden the Irish judiciary’s generally cautious approach to claims for injuries of this nature. In Ireland currently, a person is most commonly compensated for psychological injuries when they arise in connection with a physical injury, rather than as a standalone psychological injury. The new Directive underlines the need for producers to consider the psychological impact of a product in product risk assessments or warnings in product literature. The new Directive underlines the need for producers to consider the psychological impact of a product in product risk assessments or warnings in product literature.

3. Standard of Proof

In order to address perceived difficulties faced by claimants in complex cases, the new Directive introduces a number of rebuttable presumptions. These broadly reflect the approach taken by the European Courts in claims involving medical device and pharmaceutical products. Under the new Directive, the Courts may presume defectiveness or causation in cases where the claimant faces “excessive difficulties” in proving their case due to technical or scientific complexity, or where the alleged damage is deemed to be typically consistent with the defect. The new Directive indicates that national courts should assess such “excessive difficulties” on a case-by-case basis and allow defendants contest the existence of such difficulties. The introduction of these rebuttable presumptions and the basis for each will likely result in an increase in interlocutory and case management applications where claimants seek to rely on the new Directive’s burden of proof provisions.

4. Enhanced Disclosure Obligations

Requests for disclosure are common in product liability cases concerning the life sciences sector. The new Directive introduces EU-wide document disclosure obligations, which will have a significant impact in EU jurisdictions where, in contrast to Ireland, a document disclosure procedure is not available to litigants or is limited in extent.

The disclosure obligations have been introduced to address the perceived asymmetry of information between producers and claimants, which is more pronounced in jurisdictions without existing document disclosure requirements.

Failure to comply with the new requirements under the Directive will give rise to a rebuttable presumption that a product is defective. In practice, this may be a more useful tool for plaintiffs in Irish proceedings than the current and more extreme option to apply to strike out a defence for failure to make proper discovery. The new redress underlines the need for discovery to be properly and carefully done in accordance with best practice.

Notably, the Directive also obliges the courts to consider the protection of confidential information and trade secrets when determining disclosure.

5. Greater Weight for Regulatory Actions

Under the old Directive, a product is deemed to be defective if it fails to provide the safety that a person is entitled to expect. The new Directive broadens the definition of defect to encompass situations where products do not meet mandatory safety requirements under national law. Regulatory interventions such as recalls, safety notices or other actions by competent authorities may also be relevant to the assessment of defectiveness. This highlights the importance of positive and clear communication with regulatory authorities and robust record management of regulatory compliance actions.

6. Product Warnings and Foreseeable Misuse

The new Directive confirms that warnings or information in product literature cannot, by themselves, render an otherwise defective product safe.  The risk of liability under the new Directive cannot be avoided by listing all conceivable side effects of a product and manufacturers should continue to draft product literature based on a careful assessment of clinical evidence.

Courts will also consider the reasonable misuse of a product when assessing defect, which may lead to a finding that a product is defective when a consumer fails to use the product as intended, but where that failure was reasonable based on a lack of clear instructions. Life science producers should therefore continue to ensure that product instructions are as clear as possible.

7. Introduction of Representative Actions

The EU’s Representative Actions Directive, now in force across most Member States, allows qualified entities (such as non-profit consumer or patient groups) to bring collective actions on behalf of affected individuals, including for product liability claims. This development could increase the volume of product liability litigation in the life sciences sector in the EU. The Danish and Finnish medicines agencies are amongst the qualified entities designated to bring cross-border representative actions so far.

Practical Steps for Life Sciences Organisations

• Risk Assessment: Regularly review and update internal risk assessments to reflect the expanded scope of liability, including liability related to psychological harm and the role of digital services or products that interact with your product.
• Product Development: Consider psychological risks and foreseeable misuse during design and testing processes. Ensure that product literature is clear and concise.
• Document Management: Prepare for disclosure in litigation by reviewing document retention policies. Inform staff that communications may be disclosed in litigation and ensure that key decisions on product safety are well-documented and accessible.
• Regulatory Strategy: Monitor regulatory developments closely and where compliance with conflicting or unclear regulations is complex, record the reasons why a course of action was selected.
• Litigation Readiness: Review insurance coverage, consider the implications for supply chain partners and digital service providers, and review contractual terms along the supply chain.

Conclusion

The new Product Liability Directive represents a shift in the liability landscape for the life sciences sector. By clarifying and expanding the scope of liability and compensable harm, alleviating the burden of proof in complex claims, and reinforcing disclosure obligation and regulatory alignment, the Directive provides an opportunity for a renewed emphasis on proactive risk management and compliance ahead of the 9 December 2026 transposition deadline. Taking a strategic and coordinated approach now will help mitigate future litigation risk and support continued innovation in the new liability environment.