18 décembre 2024
2024 was a year of significant policy developments and legislative changes by the EU legislator to improve consumer protection and redress. In addition to the new General Product Safety Regulation (GPSR), which came into force on 13 December 2024, and the growing importance of the EU class action regime under the Representative Actions Directive, a big milestone for consumer redress was recently the adoption of the new EU Product Liability Directive 2024/2853 on 23 October 2024. It will replace the existing Product Liability Directive 85/374/EEC from nearly 40 years ago. The New Product Liability Directive aims to modernize the product liability rules and remove obstacles for consumers. Below we provide an overview of what medical devices companies should know about the new product liability rules and how they can prepare in 2025.
The New Product Liability Directive is relevant to all companies placing products on the EU market. It regulates when companies are liable for damage caused by a defect in their product. A product is defective when it does not provide the level of safety that a person is entitled to expect. Importantly, the test remains one of strict liability, meaning that consumers do not have to prove negligence or fault of the company. Product liability only requires that i) a product was defective, ii) a person suffered damage and that iii) there was a causal link between the defect in the product and the damage suffered.
One of the main aims of the New Product Liability Directive is to modernize the product liability rules and adapt them to the digital age. The manufacture and sale of products has changed considerably since the Old Product Liability Directive from 1985.
The New Product Liability Directive therefore includes the following amendments:
A further aim of the New Product Liability Directive is to remove obstacles of consumer redress. The New Directive therefore makes it significantly easier for claimants to bring product liability claims for defective products.
The New Product Liability Directive includes the following amendments:
In addition to the New Product Liability Directive, manufacturers and providers of digital health products or medical products with AI components should keep an eye on the EU plans for an AI Liability Directive in the future.
The European Commission published the proposal for the AI Liability Directive in September 2022 as part of a package with the AI Act and the New Product Liability Directive. While the latter two have since been adopted, the legislative process for the AI Liability Directive has stalled. On September 19, 2024, the European Parliamentary Research Service published a study on the draft of the AI Liability Directive, which is currently being discussed. If adopted, the AI Liability Directive, together with the New Product Liability Directive, will form a civil liability system to hold manufacturers and providers of AI systems and software fully accountable.
There are however differences between the two directives. Under the New Product Liability Directive, manufacturers or providers of defective AI systems that cause physical harm, property damage or data loss to individuals are liable without fault. The draft AI Liability Directive, on the other hand, covers non-contractual fault-based liability, for any type of damage (including pure financial losses and non-material damages) and in favor of any type of injured party (including legal entities).
The New EU Product Liability Directive introduces a more claimant-friendly product liability regime in the EU and reduces legal certainty for businesses. This can have a significant impact on medical devices companies as it will make it easier for consumers to bring claims in the EU for defective products, particularly where there are evidential difficulties caused by complex scientific and technological concepts.
The New Product Liability Directive will have to be implemented by Member States by 9 December 2026. The old Product Liability Directive 85/237/EEC will continue to apply to products already on the market by then. Companies should use the time to review regulatory compliance, review their product liability risk profile, review their insurance coverage, review existing monitoring and recall systems and review their third party seller agreements for the distribution of the product liability risks.