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.
- 14 Jan 2020The European Commission announces the European Medical Device Nomenclature (EMDN)
- 17 Dec 2019How to use HIN for Drug Supply Chain Security Act (DSCSA) requirements
- 04 Dec 2019European Commission releases updated EUDAMED Data Dictionary
- 05 Nov 2019HIBC Basic UDI-DI Guidance and Generator Now Available to Meet European Union Requirements
- 30 Oct 2019Important Notice to HIBCC Labelers