Day: June 18, 2025

The German Accessibility Strengthening Act (BFSG), implementing the European Accessibility Act Directive (EU 2019/882), takes effect on June 28, 2025. While medical devices themselves are not within the scope as a product category, accessibility requirements may still apply where medical device software operates on EAA-covered hardware (e.g., smartphones, tablets). E-commerce services, including webshops selling medical […]

The post Germany’s implementation of the European Accessibility Act (EAA) – Are medical devices affected? appeared first on Healthcare & Life Sciences Blog.

AI as a medical device (AIaMD) in Europe is at a crossroads. As manufacturers grapple with compliance under two separate legal regimes – the EU AI Act (AIA) and EU Medical Device Regulations (MDR) – concerns are mounting around the sluggish pace of Notified Body designations and glaring inconsistencies between the two frameworks. Can the […]

The post The EU AI Act and Medical Devices: Innovation or Insanity Ahead?  appeared first on Healthcare & Life Sciences Blog.