EU enforces stricter liability for life sciences products

The European Union has introduced a new product liability directive, replacing the previous directive 85/374/EEC, to address modern technological advancements and bolster consumer protection.

Effective December 2026, the legislation seeks to harmonise liability standards across the EU, compelling pharmaceutical and medical device companies to revise their product-related practices.

No-fault regime

The new directive (EU) 2024/2853 addresses the evolving landscape of product liability, particularly in light of advancements in technology, including artificial intelligence (AI), and the increasing complexity of global supply chains.

Adhering to the current standard, the legislation establishes a no-fault liability system for defective products, meaning that economic operators can be held liable for damage caused by their products without the need for the injured party to prove fault. This system ensures a fair distribution of risks inherent in modern technological production. The directive encompasses all movables, including (medical) software, whether integrated into other movables or installed in immovables.

Several fundamental principles are embedded throughout the text to enhance consumer protection and legal certainty. Firstly, the definition of "product" is clarified to include software and digital manufacturing files, ensuring that liability rules apply to both tangible and intangible products. Secondly, liability is extended to related services that are integrated into or inter-connected with a product, as these services determine the product's safety. Thirdly, the importance of product safety and market surveillance legislation in assessing defectiveness is emphasised, ensuring coherence with existing regulations.

Pharma and medical device relevance

The new EU law profoundly impacts the biotech and medtech sectors, which are known for their stringent safety standards and complex regulatory landscapes. It recognises the unique requirements of these industries by permitting Member States to maintain or introduce specialised liability systems for pharmaceutical products, provided they do not compromise the directive's efficacy.

Pharmaceutical companies and medical device manufacturers must ensure that their products comply with the revised safety obligations, including safety-relevant cybersecurity requirements where applicable. This is crucial for medical technologies reliant on software or digital services, as failure to maintain safety through updates could result in liability.

The legislation also addresses the issue of defectiveness in products whose purpose is precisely to prevent damage, such as certain health technologies. The assessment of defectiveness should consider the product's failure to fulfil its intended purpose, necessitating that manufacturers ensure their products perform as expected and provide necessary safety.

Health information and regulatory documents

The new directive's emphasis on product safety and consumer protection may necessitate updates to regulatory documentation for life sciences products. Manufacturers must provide clear and comprehensive information on the safety and use of their products, including labelling, design, technical features, composition, packaging, and instructions for assembly, installation, use and maintenance.

However, the new rules stipulate that warnings and other information cannot render an otherwise defective product safe. Manufacturers must ensure their documentation accurately reflects the safety and performance of their products and does not solely rely on warnings to mitigate risks.

In addition, manufacturers are legally required to consider the reasonably foreseeable use of their products, including misuse that is not unreasonable under the circumstances. This means that regulatory documentation should address potential misuse scenarios and provide guidance on safe usage.

These requirements complement the existing pharmaceutical legislation that is currently under review at EU level and recently revised European medical devices regulations that already mandate stringent safety and efficacy standards. The new law reinforces the need for precise information across all mandatory documentation and labelling, ensuring comprehensive coverage of product safety.

Life sciences' supply chain

The new rules introduce a number of considerations for supply chains, particularly regarding distributors' liability. Distributors can be held liable if they fail to identify the relevant economic operator responsible for a defective product within one month of receiving a request from the injured person. This provision ensures that injured persons can seek compensation even if the manufacturer or importer cannot be identified.

Liability is further extended to fulfilment service providers, who play an increasingly significant role in enabling access to the EU market for products from third countries. These operators can be held liable for example if no importer or authorised representative is established in the Union.

Online platforms that allow consumers to conclude distance contracts with traders are also subject to liability if they present the product in a way that would lead an average consumer to believe that the product is provided by the platform itself or by a trader acting under its authority or control. This ensures that consumers are protected when purchasing their health products through online platforms.

Reliance on product safety rules

The directive relies on the existing EU product safety and market surveillance framework to ensure the safety of products and protect consumers. It aligns with the new legislative framework (NLF) established under Decision 768/2008/EC, recently completed by the EU AI Act. This alignment ensures consistency with other pieces of EU law and facilitates the implementation of the new legislation.

To assess defectiveness, a number of relevant product safety requirements should be considered for compliance with new legislation, including safety-relevant cybersecurity requirements. This ensures that manufacturers follow the latest safety standards and address potential cybersecurity vulnerabilities that could affect product safety.

As regards monitoring and enforcement, cooperation between national authorities responsible for enforcing consumer protection law and market surveillance authorities is a cornerstone of the new law. This cooperation ensures relevant information exchange and enables injured persons to exercise their right to compensation effectively.

Osborne Clarke comment

The new product liability directive represents a significant upgrade in the EU's approach to product liability, particularly for the life sciences sector. By confirming the no-fault liability system and extending it to software and related digital processes, it ensures that manufacturers and relevant operators are held accountable for the safety of their products.

Pharmaceutical companies and medical device manufacturers as they prepare for the December 2026 deadline are encouraged to review their product information and practices to align with the EU's stringent safety requirements and address potential misuse scenarios. Additionally, the directive introduces new considerations for supply chains, particularly regarding distributors' liability and the roles of fulfilment service providers and online platforms.