In this edition, we spotlight the seismic shifts reshaping the laws of product liability and regulatory compliance across the EU’s pharma, biotech and medical device sectors. With the introduction of the new Product Liability Directive (PLD), businesses face a broader scope of liability, new evidentiary burdens, and wider exposure across supply chains. Our lead article breaks down these changes, while the second dives into the practical challenges companies will encounter - and how legal teams can proactively mitigate risk before the December 2026 implementation deadline.
We also take a closer look at the new disclosure obligations under Article 9 PLD, helping counsel understand what’s expected and how to prepare. From new rules under the GPSR/MDR to best-practice guidance on corrective actions, this issue is packed with insights to support life sciences companies navigating complex compliance landscapes.