The debate of the new Product Liability Directive comes as the EU Council seeks to bring the bloc’s product liability framework top to date – Photo: European Council

The EU Council will debate amendments of the new Product Liability Directive (PLD) today.

The revision seeks to bring the EU’s product liability framework up to date by considering the complexity of newer digital technologies, like artificial intelligence, and to ensure European citizens’ digital protection. The new directive aims to determine whether a manufacturer is legally responsible for one of the product’s components, in cases where a manufacturer must assess defectiveness, if a product is significantly altered or if the defect could not be known at the period of market launch.

The applicability of the new liability rules is postponed until two years after it enters into force and would applyto products put on the EU market by 2024-2025. EU Member states are also expected to take two years rather than one to shift the directive into their national framework. In doing so, the EU hopes that this will help to limit national fragmentation of EU tech legislation in the future.

These changes would likely lead to an increase of EU consumer claims against life sciences manufacturers and suppliers. The revision would also likely bring about a foundational shift in the European risk landscape for manufactures and suppliers of pharmaceuticals, medical devices, health-tracking software and other products.