EU Device Group Releases Guidance on Eudamed Compliance
The EU’s Medical Device Coordination Group issued guidance on how devicemakers should register devices that do not have unique device identifiers (UDIs) with Eudamed—the EU’s new medical device database.
The guidance describes legacy devices as those covered by a valid EU certificate that will continue to be placed on the market after the Medical Device Regulations go into effect on May 26, 2020.
The new guidance notes that there are some inconsistencies in the timelines, largely because the database is still being developed and it may not be functional by the deadline. In addition, the MDR is not explicit in requiring that legacy devices are subject to relevant UDI obligations.
Devicemakers will have until November 2021 to register with Eudamed. But if the system is not fully functional by that time, they will have until May 2022 to register.