EUDAMED update

The latest news from the European Commission is that a fully functional EUDAMED is now not likely to be available until late 2026. Originally scheduled to be completed in May 2020, the much delayed roll-out is now taking place in phases, rather than all modules at one time. While some modules are already available, European officials expect it to take nearly another two years to finalize the rest of the system, with the end of 2024 being the new anticipated release date, according to attendees at the Eudamed working group meeting which took place on 4 July 2023.

Once Eudamed is fully functional, industry will have six or 24 months before it is mandatory to use the system. The longer transition period applies to the unique device identifier (UDI)/device and notified body certificate modules.