What is a HIBC Basic UDI-DI?
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 HIBC Basic UDI-DI satisfies the Basic UDI-DI requirements in the European Union’s Medical Device Regulation (MDR) and In-Virto Diagnostic Regulation (IVDR). 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 download the full guidance document click here.
Note to Labelers: The HIBC Basic UDI-DI is an additional identifier and does not replace the UDI Device Identifier (DI) and Production Identifier (PI). The HIBC Basic UDI-DI does not appear on any device labeling. Labelers should continue to follow the guidelines in the HIBC Supplier Labeling Standard to create UDI DIs and PIs.
Example:
++A999MODELIDENTIFIER11S8
