The use of EUDAMED is not yet mandatory nor required. Some modules are already available, and can be used voluntarily. However, their use cannot be imposed. In particular:

• The module on Actor registration is available for voluntary use since December 2020
• The module on UDI/device registration is available for voluntary use since October 2021
• The module on Notified Bodies and Certificates is available for voluntary use since October 2021 except for the mechanism for scrutiny and the clinical evaluation consultation procedure (CECP) functionalities.
• The remaining modules, Vigilance, Clinical Investigation & Performance Studies and Market Surveillance, are under development and will be released when the entire EUDAMED system (including all six modules) is declared fully functional.

The mandatory use of the system will start when the entire EUDAMED system (including all 6 modules) has been declared fully functional following an independent audit and a Commission notice to be published in the Official Journal and in accordance with the transitional provisions set out in the medical devices regulations.