Software (including AI) for medical purposes is regulated in Europe and the United Kingdom as a medical device. It requires comprehensive assessment before being placed on the EU and UK market under Medical Device Regulations (MDR) and the EU In Vitro Diagnostic Medical Devices Regulation (IVDR). The European Union (EU) has introduced new legislation on Artificial Intelligence (AI): The “AI Act” (Regulation 2024/1689) because the current framework does not fully address the ethical and transparency risks associated with AI. Like the General Data Protection Regulation (Regulation 2016/679 - GDPR), the AI Act applies to providers wherever they are in the world if they place or…