European Medical Device Regulation: Clinical Evaluation and Post-Market Surveillance

Course Description

Regulations for medical devices in the European Union are going through the most comprehensive revision since they were created in the 1990s. These revisions are driven in part by technological advancement. They are also aimed at ensuring safety and effectiveness of medical devices in response to several high-profile product scandals in recent years. Key changes have resulted in clinical evidence requirements, pre-market review of the technical file by notified body, post-market surveillance and vigilance, transparency and traceability through Unique device identification (UDI) and strengthening of the oversight of the medical devices by the notified body.



As the EU transitions to this new standard of regulations, medical device companies need to prepare to be in alignment with new standards. Not only do new device designs need to be in compliance with new standards, but all existing products and technologies must be recertified.


Students in European Medical Device Regulation will learn the details of the new regulations, and how to serve their organizations’ needs for highly qualified regulatory affairs, clinical affairs, and quality assurance professionals.