MEDICAL DEVICES AND PRODUCT LIABILITY CONCERNS IN THE EU
Medical device manufacturers already face varying and stringent product liability regulations, but a regulatory shift is coming in the European Union (EU). In 2024, the EU legislator introduced significant policy developments and legislative changes concerning consumer protection and redress. Notably, the new General Product Safety Regulation came into force on 13 December 2024, and the EU class action regime under the Representative Actions Directive gained importance.
A major milestone for consumer redress was the adoption of the new EU Product Liability Directive 2024/2853 on 23 October 2024. The EU’s product liability framework will be updated following the publication of the Directive. Member states must implement its provisions by 9 December 2026. The old Product Liability Directive 85/374/EEC will continue to apply to products already on the market by that date.
The new Directive will replace the existing one that was introduced around 40 years ago. While innovative at its inception in 1985, the previous framework has become largely obsolete due to rapid technological advancements and globalisation. The nature of products has changed dramatically, with digital and artificial intelligence (AI)-driven goods now commonplace. Additionally, the complexity of supply chains has increased, making it more challenging to pinpoint liability in cases of product defects.
For its proponents, the Directive is more than a regulatory update; it is a necessary evolution reflecting the dynamic nature of today’s market and the EU’s commitment to consumer protection and innovation. The new Directive aims to modernise product liability rules and remove obstacles for consumers, particularly as companies adapt to technological developments.
Jul-Sep 2025 issue
Richard Summerfield