After a long wait, October 4th, 2021, marks the date the European Commission made the UDI/Device Registration module 2 of Eudamed available:
This means that Medical Device manufacturers are now able to upload all the information related to their MDR devices on a voluntary basis until 6 months after Eudamed being fully functional, when it will become mandatory.
For legacy medical devices the possibility of carrying out this register on a voluntary basis is also there until 24 months after Eudamed has achieved full functionality. Nonetheless, manufacturers should take into account that register is mandatory for legacy devices where a serious incident has occurred or field safety corrective action has been applied.
- Strategy definition for Eudamed registration
- UDI request (Basic UDI-DI, UDI-DI, EUDAMED DI, EUDAMED ID)
- Data mapping
- Data upload
- QMS support for Eudamed maintenance
If you are interested in receiving further details, do not hesitate to book a free meeting with us here: Asphalion Meeting Point
📌 SAVE THE DATE! You will also have the opportunity to get to know more about this module by participating in the free online webinar: ‘EUDAMED: MODULE 2’ on November 17th 2021, 3:00 p.m. EST, where our experts Ramón Hernández and Francisco Rodríguez will address the newest updates on Eudamed. Stay tuned for further updates!!