This tutorial will give a condensed overview of the EU device legislative system and the principles and philosophy supporting them. It will also explain the definition of a medical device, the delineation between medical devices and pharmaceuticals and the provisions on combination products. Legal provisions for medical software, regulated as a medical device will be highlighted. The characteristics and the organisational structure of the medical device sector and the role of the various stakeholders will be discussed as well as the concept of risk classification of medical devices and the relationship between risk classification and conformity assessment procedures.

The tutorial will cover the headlines of the EU regulation of in vitro diagnostics, with a focus on the differences to the medical device regulation. Theoretical concepts will be illustrated and supported by practical examples. Finally, we will look ahead into the main changes resulting from the ongoing revision of the medical device and in vitro diagnostic regulations.