The courses in this module will give you an overview on the Medical Devices and their regulatory framework. You will learn about the history of the Medical Devices, different classifications, the role of Notified Bodies and Conformity Assessment, CE marking and re-certification. You will also acquire knowledge about the Medical Devices development and the lifecycle management under the MDR and IVDR and new technologies in the context of Medical Devices and in vitro diagnostics (IVDs). You will learn about the general principles for market access and market access for Medical Devices and the different aspects of Value-based innovation. These courses also provide key definitions about Health Technology Assessment (HTA) in Medical Devices and HTA principles in Medical Devices and in vitro diagnostics (IVDs).