The European Commission (EC) released an FAQ document on the European Medical Device Nomenclature (EMDN). The EMDN is intended to support the functioning of EUDAMED and will be utilized during the UDI/Devices Registration Module.
The UDI/Devices Registration Module is projected to be available to manufacturers beginning in September of 2021 (previously May 2021).
To view the FAQ document click here
To learn more about HIBCC and UDI, visit www.hibcc.eu or contact HIBCC directly at firstname.lastname@example.org or +1 (602) 381-1091.
- 09 Jun 2021EC publishes FAQ on the European Medical Device Nomenclature
- 19 May 2021EC publishes guidance addressing MDR requirements in the event EUDAMED is not fully functional
- 25 Mar 2021Is your software considered a medical device under the EU MDR/IVDR?
- 15 Mar 2021EC publishes MDR guidance on Custom-Made Devices
- 17 Feb 2021Register now for our HIBCC EU UDI Webinar