State of the Art (SotA)

The European Medical Device Regulation 2017/745 (MDR) and In-Vitro Diagnostic Regulation 2017/746 (IVDR) often state the need to “take into account the generally acknowledged state of the art”. However, the concept of the “state of the art” (SotA) is not legally defined and thus differs between various guidance documents. The International Medical Device Regulators Forum (IMDRF) has provided the following definition of the SotA for medical devices: Developed stage of current technical capability and/or accepted clinical practice in regard to products, processes and patient management, based on the relevant consolidated findings of science, technology and experience. Note: The state-of-the-art embodies what is currently and generally accepted as good practice in technology and medicine. The state-of-the-art does not necessarily imply the most technologically advanced solution. The state-of-the-art described here is sometimes referred to as the ‘generally acknowledged state-of-the-art (IMDRF/GRRP WG/N47 FINAL:2018 Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices).