Date: 19th (1) and 20th (2) of January 2021 (2 sessions)
Time: 09:00h -12:00h CET
Costs: € 895,-
EUDAMED is the IT system developed by the European Commission to implement MDR Regulation (EU) 2017/745 on medical devices and IVDR Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
EUDAMED will improve transparency and coordination of information regarding medical devices available on the EU market. The system will be multipurpose. It will function as a registration system, a collaborative system, a notification system, and a dissemination system (open to the public) and will be interoperable.
- Introduction to EUDAMED
- Registration of Economic Operators
- Registration of UDI & Device
- Data Submission
- Implementation and QMS impact