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...