Impact on medicines and medical devices
Medicines and medical devices are subject to the EU’s general product liability rules, including the EU’s Product Liability Directive (PLD). The European Commission’s proposal for a new PLD seeks to make the PLD fit for purpose in the 21st century and address challenges faced by those who have suffered damage to claim compensation. In doing so, the Commission has expanded the scope of the PLD so that it will now cover movable products (i.e., software), which will include medical technology, such as physical medical devices which rely on artificial intelligence (AI), as well as medical smartphone apps. All those involved in the supply of medicines and medical devices (including those which rely on AI) into Europe will be affected by this proposal.
Our recent alert on the change can be read in full here.