MD01: An Introduction to the Regulation of Medical Devices

Description

This module provides an introduction to the basics of medical device regulation, especially the requirements that manufacturers must meet in order to market devices in Europe and the USA.

We explain what medical devices are and give examples of the various types. We outline the principles of their regulation and the criteria for placing them on the market. We identify major players in regulation worldwide.

We then outline 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.