Non-US regulatory

The design and execution of any research endeavor in the field of interventional radiology is developed through much the same avenues as other medical subspecialties as a whole in the era of evidence-based medicine; however, clinical and translational research efforts regarding IR and other predominantly proceduralist subspecialties are invariably tied not only to written theories on the pathophysiology of various disease states and their corresponding medical management, but also the added responsibility of being able to pioneer, develop, and evaluate numerous different kinds of medical devices and the underlying biologic mechanisms that contribute to their efficacy as well as any potential risks to the patient. It is therefore essential for the IR operator to understand the various regulatory bodies responsible for ensuring the safety of patients when it comes to future research as well as new medications and medical devices on a more broadened and international scale, especially since a growing body of lesser-known novel transcatheter techniques often may originate in various international research groups of interventionalists, which then gradually assimilate into clinical practice in the United States (US) over a number of years. Therefore, we present a current overview of European regulation with respect to designing and conducting research, as well as new medications and medical devices.