After a long wait, October 4th, 2021, marks the date the European Commission made the UDI/Device Registration module 2 of Eudamed available:
https://ec.europa.eu/tools/eudamed/#/screen/home
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.
From Asphalion, we highly encourage not to wait until the last minute and to start gathering all the relevant data as soon as possible. At Asphalion we can assist you with:
- 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!!
