The EU Commission updated the EUDAMED timeline chart again this month, with a new ‘go-live’ date of Q2 2024. This delays EUDAMED by another year.
Criteria for EUDAMED Launch
As the first step, EUDAMED must pass an independent audit and be deemed fully functional. After this occurs, it will be published in the Official Journal of the European Union (OJEU). After OJEU publication, a six-month transition period will commence.
New EUDAMED Dates
After the 6-month transition period ends, the following EUDAMED modules become mandatory:
- Actor registration
- Clinical Investigation & Performance Studies
- Market Surveillance
This means, if the Q2 2024 fully functional date is met, then EUDAMED is mandatory for the above four modules in Q4 2024.
The following EUDAMED modules have a 24-month transition period:
- UDI/Device registration
- Notified Body & Certificates
This means, if the Q2 2024 fully functional date is met, then EUDAMED is mandatory for the above two modules in Q2 2026.
Device Registration in the Meantime
Unless another mechanism is put into place, the registration requirements of the old Directives will continue to prevail through Q2 2026, even as MDD/AIMDD devices may no longer be legally placed onto the European market.
Voluntary Use of EUDAMED
In the meantime, three of the six EUDAMED modules are currently available for voluntary use: Actor registration, UDI/Device registration and Notified Body & Certificates modules.
Still pending release are the Vigilance & Post-market Surveillance, Clinical Investigation & Performance Studies and Market Surveillance modules.
History of EUDAMED ‘go-live’ Deadline
- Original EUDAMED date: 26 May 2020
- First postponement, new date: 26 May 2022
- Second postponement, new date: Q2 2023
- Third postponement, new date: Q2 2024
For more information, please read: EUDAMED Basics