Introducing artificial intelligence (AI)-based medical devices to the European market demands more than cutting-edge technology. Achieving compliance with the EU Medical Device Regulation (MDR 2017/745) hinges on a comprehensive understanding of the regulatory landscape governing product safety, clinical performance, and market approval. Notably, the clinical data requirements necessary for CE marking represent some of the […]
Introduction to EU MDR The European Medical Device Regulation (EU-MDR) 2017/745 took effect on May 26, 2021. It replaced the Medical Device Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD). This newer framework introduces more demanding requirements to bolster product safety, performance, and post-market tracking. Medical device manufacturers must create an EU MDR […]
