Document paper International

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.

Posted on 01.05.2013

Fotolia_65222764_Subscription_Monthly_M.jpg

European Value-Based Procurement Conference

Join us for the 4th edition of the European Value-Based Procurement Conference which will be held on 15 December 2022.

Related content