Impact on medicines and medical devices

In brief

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


Els Janssens is a counsel specialised in healthcare life sciences regulatory matters based in Brussels. She has more than 10 years of experience with life sciences industry in the UAE.


Lauren Gest is an associate in the Baker McKenzie Dispute Resolution team in London and a member of Baker McKenzie's Healthcare and Life Sciences industry group.