The HIBC Basic UDI-DI satisfies the Basic UDI-DI requirements in the European Union’s Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR). The HIBC Basic UDI-DI enables manufacturers to connect and identify devices with the same intended purpose, risk class and essential design and manufacturing characteristics. The Basic UDI-DI is required in the EU’s EUDAMED database and is referenced in relevant documentation (i.e. certificates and technical documentation).
To view the HIBC Basic UDI-DI Guidance click here.
To access the HIBC Basic UDI-DI Generator 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.
- 05 Nov 2019HIBC Basic UDI-DI Guidance and Generator Now Available to Meet European Union Requirements
- 30 Oct 2019Important Notice to HIBCC Labelers
- 30 Oct 2019European Commission confirms two year delay for the launch of EUDAMED. Labeling deadlines are not affected by this delay.
- 11 Oct 2019The HIBC UDI-Builder is now available. This tool will allow you to create, calculate, confirm, and collect UDIs.
- 09 Oct 2019European Union Medical Device Coordination Group (MDCG) releases document concerning the validity of existing certificates