(2021) SEMI-ANNUAL EUROPEAN MEDICAL DEVICE AND DIAGNOSTIC CLINICAL EVIDENCE STRATEGY CONFERENCE

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.