What is the latest?
EUDAMED development is progressing further with the publication of two new modules: UDI/Devices registration and Notified Bodies & Certificates. This means, three of the six EUDAMED modules are now available on the European Commission website.
With these new modules manufacturers and notified bodies can begin inputting device data into the EUDAMED system on a voluntary basis.
The final three modules are expected in May 2022.
|Actor Registration||Dec 2020|
|UDI/ Devices registration||Oct 2021|
|Notified Bodies and Certificates||Oct 2021|
|Clinical Investigations and performance studies||Expected May 2022|
|Vigilance and post-market surveillance||Expected May 2022|
|Market Surveillance||Expected May 2022|
Economic Operator Registration
Although EUDAMED will not be mandatory until two years from the date it is fully functional if you are an Economic Operators (EU and non-EU Manufacturers, Authorized Representatives, system manufacturers, and medical devices and in-vitro diagnostic medical devices importers) it is recommended that you complete your registration in the system to receive your Single Registration Number (SRN) code.
As the Economic Operator registration for manufacturers must be reviewed by both the manufacturer’s AR and Competent Authority, there may be a backlog of reviews once it is closer to the mandatory deadline. So, if you want to avoid this potential issue, you can register now.