Sign up for our Newsletter!
Stay current on regulatory affairs in Europe, the UK & Switzerland.
Sent once a month. Unsubscribe at any time.
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.
The revised timeline chart can be found: HERE
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.
After the six-month transition period ends, the following EUDAMED modules become mandatory:
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 further 18-month transition period:
This means, if the Q2 2024 fully functional date is met, then EUDAMED is mandatory for the above two modules in Q2 2026.
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.
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.
Sign-up for our Newsletter!
Stay current on regulatory affairs in Europe, the UK & Switzerland.
Sent once a month. Unsubscribe at any time.
Sign-up for our Newsletter
Sign up for our Newsletter!
Stay current on regulatory affairs in Europe, the UK & Switzerland.
Sent once a month. Unsubscribe at any time.