Medical Device Regulation

This thesis analyses the regulation of medical devices in the United States of America and in the European Union. It covers the principles of health economics and fundamental aspects of the regulation of medical devices in both trade regions. It will focus on the legal framework and the different approaches used to secure patient health and safety. The role of EU Member States and the European Commission as competent authorities in the EU and the FDA as a governmental body in the US is explained. Case studies from both regimes will demonstrate failures and changes for the regulation of medical devices are proposed at the end of the thesis.