Medical Device Regulation: Overview

This lecture provides an overview of the Medical Device Regulation (MDR) in Europe, focusing on the regulatory framework, safety considerations, and the transition from previous directives. It covers the impact of MDR on medical device classification, clinical data requirements, conformity assessment, and the role of Notified Bodies. The instructor discusses the importance of standards, the CE-marking process, and the differences between regulations and standards. Additionally, the lecture explores the clinical evaluation process, the involvement of various authorities in protocol approval, and the differences between the regulatory systems in Europe and the USA.