The European Commission has designated HIBCC to be a Unique Device Identifier (UDI) Issuing Agency as part of the European Union Medical Device Regulation (MDR), which will apply to all EU member nations. HIBCC’s EU Issuing Entity designation was announced on June 7th, 2019. HIBCC has been an Issuing Agency for the U.S. FDA’s UDI Rule since 2013.
HIBCC will be deploying additional support and guidance to its European constituents to assist them as they implement processes in accordance with the EU MDR.
To view the official EU Issuing Entity designation click here.
To view the entire release from the Official Journal of the European Union click here.
To learn more about EU UDI requirements click here or contact HIBCC directly at email@example.com or (602) 381-1091.
- 27 Jan 2020Notice to Labelers: HIBCC Contact Information
- 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