Course Overview

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.

Learning objectives

1. Define and give examples of the various categories of medical device.
2. Outline the principles of medical device regulation and the criteria for placing devices on the market.
3. Identify major players in the regulation of medical devices worldwide.
4. Identify legal statutes and sources of regulatory guidance on medical devices in the European Union and the USA.
5. Outline prominent characteristics of the regulation of medical devices in the USA.
6. Outline prominent characteristics of the regulation of medical devices in the European Economic Area