This symposium will provide an overview of the latest development and EU Commission's proposals on the Revision of Medical Device Directives including In-Vitro Diagnostics Directive in comparison to the current legislation will be provided. Notified Body representative will analyze the impact of the revised legislation will have on the system of third party assessment in Europe; and highlight those elements changed in the supervision by the third parties on industry and other stakeholders as consequence of the revised legislation. Further, the impact of the revised legislation on the company procedures and strategy will be provided. Additionally, an overview on the current and future reporting of serious adverse events from medical device trials in Europe will be provided.

Learning Objectives:
Discuss the EU Commission's proposals on the Review of Medical Device Directives
Describe the revision of the In Vitro Diagnostic Directive comparison to the current legislation
Identify the impact of the revised legislation on the system of third party assessment in Europe.