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)...
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...
8/4/2025 9:40:31 AM Council adopts its position on EU pharmaceutical law reform: focus on antimicrobials and transferable data exclusivity vouchers By Caroline Arrighi-Savoie Nour Saab Margot Pietri This article is part of a series covering updates to the proposed European Union (EU) pharmaceutical legislation reform, known as the...
10/14/2024 9:22:12 AM Fight against medicine shortages: the French Medicines Agency (ANSM) imposes fines totalling €8 million By Caroline Arrighi-Savoie Johanna Harelimana Nahla Ghouali On 24 September, the French National Agency for the Safety of Medicines and Health Products (ANSM) announced fines totalling €8 million...