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Updated in [July 24th, 2023]

This short course provides an introduction to the Medical Device Regulation (EU) 2017/745. It is designed to provide an overview of the main aspects of the regulation, including the roles of the manufacturer and the notified bodies, conformity assessment, clinical evaluation and clinical investigation, CE-marking, and the MDR. The instructor for this course is an experienced medical device professional with extensive knowledge of the Medical Device Regulation (EU) 2017/745. The instructor will provide an overview of the regulation, as well as an in-depth analysis of the main aspects of the regulation. The goals of this short course are to provide an understanding of the Medical Device Regulation (EU) 2017/745, to provide an overview of the main aspects of the regulation, and to provide an in-depth analysis of the main aspects of the regulation. The main aspects of the Medical Device Regulation (EU) 2017/745 that will be discussed in this course include the roles of the manufacturer and the notified bodies, conformity assessment, clinical evaluation and clinical investigation, CE-marking, and the MDR. The manufacturer and the notified bodies are responsible for ensuring that medical devices comply with the Medical Device Regulation (EU) 2017/745. The manufacturer is responsible for ensuring that the device meets the requirements of the regulation, while the notified bodies are responsible for verifying that the device meets the requirements of the regulation. Conformity assessment is the process of verifying that a medical device meets the requirements of the Medical Device Regulation (EU) 2017/745. This includes verifying that the device meets the requirements for safety, performance, and quality. Clinical evaluation and clinical investigation are two important aspects of the Medical Device Regulation (EU) 2017/745. Clinical evaluation is the process of assessing the safety and performance of a medical device, while clinical investigation is the process of collecting data to assess the safety and performance of a medical device. CE-marking is the process of verifying that a medical device meets the requirements of the Medical Device Regulation (EU) 2017/745. CE-marking is required for all medical devices that are sold in the European Union. The MDR is the Medical Device Regulation (EU) 2017/745. The MDR is the regulation that governs the safety, performance, and quality of medical devices in the European Union. This short course will provide an overview of the main aspects of the Medical Device Regulation (EU) 2017/745, as well as an in-depth analysis of the main aspects of the regulation. The instructor will provide an overview of the regulation, as well as an in-depth analysis of the main aspects of the regulation. The course will also provide additional resources for further study. Upon completion of this course, participants will have a better understanding of the Medical Device Regulation (EU) 2017/745 and will be better prepared to comply with the regulation.