Europe and USA: different answers to the same questions The current process of approval of medical devices is profoundly different in Europe and in the United States. In Europe, a company manufacturing a new device is free to choose one of the 72 Notified Bodies, private organisations monitored by the National Health Authorities, to receive CE mark and seek subsequent approval by the National Health Authority which remains ultimately responsible for the surveillance of clinical application of the approved device. In the USA the process is centrally regulated by the Food and Drug Administration (FDA) following uniform schemes and starting from the very first, the identification of the intended use, the population of intended use, and the appropriate clinical trial design to ensure “reasonable assurance of safety and effectiveness.” There are some similarities to the drug evaluation processes, including pilot safety/feasibility trials (on actual patients rather than normal volunteers), mechanistic Phase 2 trials compared to standard therapies (instead of dosing studies), pivotal Phase 3 trials generally randomised against controls, and post-approval Phase IV surveillance processes for additional undetected safety issues. However, device evaluation must accommodate unique differences from drugs, including the rapid pace of device innovation and the interdependence of device performance with operator experience and skills. In all, the goals of evaluation include a hope to avoid widespread use of a therapy that is later found to have significant problems, leading to worldwide recalls, headline-oriented attention of the general media and shaking the stock market. If you have a chance to visit the beautiful gated citadel where several high rise building provide the new home of the FDA, just outside Washington, and compare it with the scattered offices of EMA in Canary Wharf, London, the device regulations agency still host in the Industry and Enterprises Department in Brussels, you can immediately understand the different breadth of scope of the US and European organisation, the first aiming at tight control of all steps of the approval process, the second offering more advice and orientation on the achievement of basic standards which will be supplemented by national approval.