Substantial growth of medical device software (estimated Compound Annual Growth Rate – CAGR - of 20%) is expected as the digitalization of healthcare continues. Artificial intelligence in medical device software has an even stronger growth potential as it carries the promise of better and more efficient healthcare. The application of the new regulation for medical devices in Europe (MDR 2017/745) since May 26th, 2021 introduces more stringent regulatory requirements to manufacturers of medical device software and their value chain (In vitro diagnostic medical device regulation IVDR 2017/746 will apply in 2022).
As technology development in AI can outpace regulatory updates, challenges may arise in the assessment of conformity of AI driven medical device software. Our work aims to improve clarity and efficiency of conformity assessment of AI and medical device software under the MDR through the development of position papers and digital compliance tools.
Additionally, through research projects, we explore the assurance, data quality, and risk management implications of AI in both clinical and non-clinical settings.