Artificial Intelligence (AI) is a reality in healthcare. Although AI technology has been increasingly adopted in medical devices, workflows, and decision-making processes, there is still uncertainty about the rules and regulation applying to AI in healthcare. COCIR has thus decided to conduct an in-depth analysis of how existing medical device legislation (MDR & IVDR) is applied to AI-based devices, providing an overview of all relevant legal requirements.
This analysis aims to show policy-makers, manufacturers and users that AI can be deployed in a way that is consistent with existing Regulations - ensuring medical devices based on artificial intelligence are safe and performant throughout their entire lifecycle.