Our introductory course on medical devices provides an introduction to the basics of their regulation, especially the requirements that manufacturers must meet in order to market devices in Europe and the USA. Our module explains what medical devices are and gives examples of the various types. It outlines the principles of their regulation and the criteria for placing them on the market, and it identifies major players in regulation worldwide. It then outlines prominent characteristics of the regulation of medical devices in the USA and in Europe. The module is up to date with the current upheaval in European Union legislation on medical devices.