The Product Liability Directive is coming
The new Product Liability Directive (EU) 2024/2853 (PLD) will apply in full from 9 December 2026. It sets out how individuals can claim compensation for damage caused by a defective product—including medical devices, which are explicitly within scope.
Under the PLD, manufacturers or their authorised representatives must provide the technical documentation if requested by a claimant. If they fail to do so, or if the documentation does not show that product risks were properly managed, the product is presumed to be defective and responsible for the damage.
Make sure your technical documentation is complete, compliant, and ready to stand up to the new liability rules.
