Language – French
This webinar aims to provide clarification on the new EU Regulation on medical devices (EU Regulation 2017/745) which came into force on 25 May 2021.
The new regulation outlines a more robust classification system for medical devices and sets out specific requirements for manufacturers, importers, and distributors of medical devices.
This webinar will focus on the new EU regulation on post-marketing surveillance of medical devices and will address the following issues:
– How to set up post-market surveillance of medical devices and which data to monitor?
– How does incident reporting work?
– What are the periodic reports to be written, for what purpose and what do they contain?
– How to set up a risk management plan?
At the end of the webinar, you will have the opportunity to ask our experts any questions you may have.