Evidence of clinical performance and safety of medical devices has been at the forefront of recent international regulatory reforms. Clinical evidence is crucial to bringing a device to market and is a very important aspect of post-market compliance to meet the requirements of current legislation. The collection of clinical data to demonstrate safety and performance is pivotal to CE marking a medical device and the collection of post-market data is key to the continued safety and performance considerations once the device is on the market. With the evolution of evidence requirements for medical devices indicating a greater need for clinical and real-world evidence for both approval and market access, manufacturers are paying more attention to their evidence generation plans for devices and diagnostics, and the benefits are substantial.