You are here Home Product regulation Medical devices Software and artificial intelligence Manufacturing for software and artificial intelligence Artificial Intelligence (AI) and medical device software Is my software regulated? Flowcharts showing which software products are regulated as a medical device, and those that are not. Last updated 27 July 2021 Listen Print Share LinkedIn (Twitter) Facebook Email Loading... Supporting documents Is my software regulated? [PDF, 84.94 KB] Product types Software and artificial intelligence Topics Safety monitoring and information Main navigation