Pre-marketing authorization of new medical devices in the European Union and the United States

The European Union (EU) and the United States (US) have different regulatory systems for pre-marketing approval of medical devices (MDs) that result in differences in the MDs market authorizations and dates of market entry. This study analyzed differences between the MD regulatory systems in the US and the EU and evaluated the effect of those differences in pre-marketing authorization of new MDs in the period January 2000 to September 2012.