Health software serves a wide range of functions and may be classified as a medical device under Swiss and EU legislation if it is intended for a medical purpose. In such cases, it must comply with applicable medical device regulations. The integration of artificial intelligence (AI) into medical device software introduces additional regulatory considerations and challenges. Einat Albers-Schönberg from Swissmedic provides the regulatory authority’s perspective on the use of AI in medical devices, offering insights into this evolving field.