The Changing Landscape of Medical and In Vitro Diagnostic Device Regulations in the European Union

This UL white paper offers an overview of the new Regulations applicable to medical and in vitro diagnostic devices sold in the EU. The paper begins with a brief summary of the EU’s original regulatory structure and the motivations behind the changes. The white paper then provides a summary of these changes, as well as their possible impact on device manufacturers. The paper also discusses new regulations regarding auditing and assessment activities by notified bodies, and important changes to their appointment and oversight. The paper concludes with some suggestions to effectively navigate the changing EU regulatory landscape.