The Changing Landscape of Medical in In-Vitro Diagnostic Device Regulations in the European Union
Prompted by rapid advances in medical device technologies as well as findings of safety issues with previously approved devices, the regulation of medical devices in the European Union (EU) is undergoing a sweeping transformation. The EU's newly published Regulations on medical devices include an expanded scope of regulated devices, greater oversight and control of notified bodies, greater emphasis on clinical evidence, greater transparency, and more. For most medical device manufacturers, these changes will directly impact the product review and certification process, and will increase the investment of time and resources required for product approval.
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.