B2DG-Resources

Title: 
Getting Your Device Approved in the EU
Author: 
Kristine Curran Mechem, East of England International
Brief Description: 

This presentation is an introduction to the regulatory process in the European Union. It will discuss the Medical Device Directive and the regulatory process in Europe including what is covered under the directive, which agencies are involved (e.g., EMEA, MHRA, notified bodies), the classification of devices, the CE mark and the quality standards (ISO). Additionally, it will compare and contrast the European regulatory process to the U.S. medical device regulatory process.