Last week the EC announced on their website that the availability of the MVP (Minimum Viable Product) version of the UDI / device registration module is now planned for September 2021 instead of May 2021. This also applies to the module on Certificates and Notified Bodies (third module).

The remaining modules will be displayed as soon as they are functional afterwards.

Which impact does this have on your own UDI challenge?

You should keep working on your projects and prepare the relevant product data, as the next testing phases still seem to take place in March and July. In addition, it is important to have a clear concept for Basic UDI and device assignment as this forms the basis for your MDR certification processes.

If you want to get more information regarding the availability of EUDAMED, click here or contact us.

EUDAMED UDI _device registration module postponed to September 2021