The European Union has embarked on a significant regulatory reform with the introduction of a new product liability directive, set to replace the previous directive 85/374/EEC. This legislation, which is scheduled to take effect in December 2026, aims to modernise liability standards across the EU, particularly in light of the rapid technological advancements and the intricate nature of contemporary global supply chains.
The directive, known as (EU) 2024/2853, introduces a no-fault liability regime for defective products, a shift that allows economic operators to be held liable for damages caused by their products without the injured party needing to establish proof of fault. This approach is designed to facilitate a fair distribution of risks associated with the increasingly complex production processes of modern technology.
In a statement to Health Tech World, Vladimir Murovec, Head of Life Sciences Regulatory at Osborne Clarke in Brussels, highlighted the significance of the directive for various sectors, stating that it acknowledges the evolving landscape of product liability due to advancements in technology, particularly artificial intelligence. He noted that the new definition of a "product" now clearly encompasses software and digital manufacturing files, thereby ensuring that the updated liability rules apply to both tangible and intangible products.
Furthermore, the directive extends liability to include related services that are either integrated into or connected with a product, recognising their crucial role in determining the product’s safety. The legislation also underscores the importance of existing product safety and market surveillance regulations in assessing a product's defectiveness.
The biotech and medtech industries, sectors characterised by stringent safety standards and complex regulatory frameworks, will need to adapt to these changes. Member States may retain or implement specialised liability systems for pharmaceutical products as long as these do not undermine the directive’s overarching principles. It is imperative for pharmaceutical companies and medical device manufacturers to align with the enhanced safety obligations, which include cybersecurity measures pertinent to products reliant on software or digital services. If such technologies fail to meet these safety standards, it may result in significant liability for the manufacturers.
The directive also stipulates necessary updates to regulatory documentation for life sciences products, mandating that manufacturers provide detailed information regarding the safety and functionality of their products. Important aspects such as labelling, design, technical specifications, composition, packaging, and comprehensive assembly, installation, and maintenance instructions must be included. However, it is crucial to note that the presence of warnings or other forms of information cannot render an otherwise defective product safe.
The new rules require producers to anticipate the reasonably foreseeable use of their products, including any potential misuse that should be considered reasonable under the given circumstances. Consequently, regulatory documents must equip users with guidance on safe usage while addressing possible misuse scenarios.
As the regulation extends its reach, it will alter several dynamics within the supply chain, particularly concerning the liabilities of distributors. Distributors will be held accountable if they fail to identify the economic operator responsible for a defective product upon receiving a request from the injured party. This provision ensures injured parties can seek compensation even when the manufacturer or importer is untraceable.
Moreover, the directive also implicates fulfilment service providers, who play an increasingly critical role in facilitating market access for products from third countries. These operators may face liability claims if no importer or authorised representative is designated within the EU. Similarly, online platforms that facilitate consumer contracts with traders must ensure clarity in product representation; if consumers are misled to believe that products are supplied by the platform, they too may be held liable.
The directive is designed to work in concert with the existing EU product safety and market surveillance infrastructure, ensuring a comprehensive framework for the protection of consumers. This alignment with the newly completed EU AI Act facilitates a cohesive implementation of the regulatory landscape.
In summary, the new product liability directive marks a pivotal evolution in the EU's legislative framework concerning product liability, particularly within the life sciences sector. As companies prepare for the implementation deadline in December 2026, it is critical for them to review and reform their product information and practices to comply with these stringent regulations. The directive not only reinforces the responsibility of manufacturers to ensure product safety but also introduces new considerations for supply chain dynamics, including the responsibilities of distributors and online platforms in safeguarding consumer interests.
Source: Noah Wire Services