1/15/2026 1:56:33 PM Understanding the impact of the European Accessibility Act on Medical Devices By Kelly Mackey Deirdre Kilroy Understanding the impact of the European Accessibility Act on Medical Devices The European Accessibility Act (Directive (EU) 2019/882)...
12/2/2025 4:16:31 PM Skinny labels ≠ safe harbor: evolving liability for second medical use patents in Germany By Andreas Obermeier Anna Wolters-Höhne Phoebe Greybanks Recent German court decisions have fundamentally shifted the risk landscape for generic and biosimilar companies facing second medical...
10/27/2025 11:54:53 AM Navigating the interplay of MDR and AIA: New MDCG Guidance on Medical Device AI Under the EU AI Act: EU and UK perspectives By Pieter Erasmus Maud van Haaren Hester Borgers The EU regulatory landscape for medical devices making use of artificial intelligence (MDAI) has become significantly more complex with...
8/18/2025 3:47:55 PM EU Pharmaceutical Law Reform: New Framework for Combination Products By Christian Lindenthal Annelie Säurig As part of its pharmaceutical law reform, the EU legislator has proposed a modernised framework for combination products – products that...
8/14/2025 9:55:42 AM EU Pharmaceutical Law Reform: Council advances paediatric medicine reform with more flexible investigation plan proposals By Clarissa Junge-Gierse This article is part of our series covering the proposed reforms to the EU pharmaceutical legislation. To view the entire series, click...