Developments in product liability law are always potentially significant for pharmaceutical and medical device manufacturers.

On 13 March 2024, the European Parliament adopted new EU consumer protection legislation to repeal and replace the EU Product Liability Directive 85/374/EEC, which has been in force for almost 40 years.  Once the new legislation has been approved by the European Council it will become law, and is likely to come into force in around mid-2026. The intention is for EU consumers to have easier access to compensation caused by defective products. 

The International Comparative Legal Guide (ICLG) on Product Liability Laws and Regulations 2024 is now available, and we have prepared:

Both chapters are available to read online along with the rest of the 2024 version of the Guide, containing numerous other country and analysis chapters supplied by other contributors.

Some key changes to look out for in the revised EU Product Liability Directive:

  • Amended scope of products covered, including software, AI systems and related integrated or interconnected digital services.
  • Replacement of the ‘producer’ concept by the identification of various economic operators as  potential defendants.
  • Expansion of the specific circumstances required to be considered in the assessment of defect to include, among other things, regulatory compliance and product recalls
  • A new disclosure requirement, with a rebuttable presumption of defect in the event that disclosure is not provided
  • A rebuttable presumption of defectiveness in the most technically and scientifically complex cases
  • Addition of data loss and psychological harm to the types of actionable damage and cancellation of the minimum and maximum damage thresholds 
  • Extension of the limitation period to 25 years for latent damage

For analysis of how your business should prepare for the new legislation, please contact Adela Williams, Tom Fox or Libby Amos-Stone.