The EU’s new Medical Devices Regulation and In-vitro Diagnostic Device Regulation has integrated and reinforced the regulatory requirements for pre- and post-market clinical trials and positioned them as vital to ensuring the safety and performance of a medical device on the market. These regulatory changes combined with greater access to clinical data and the technology that is now available on the market, enable manufacturers to analyse and even use clinical data in new ways. Smart algorithms can now evaluate with speed and ease a product’s clinical data to benchmark it in the context of the global market for the very first time. This metaanalysis, driven by artificial intelligence, will in turn redefine the way manufacturers approach the design of clinical trials to make them more effective, efficient, reduce waste, improve product performance and safety, discover new markets, innovate devices and secure a faster pathway to funding and reimbursement.