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.
- 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
- 25 Sep 2019HIBCC UDI Presentation Available for Download
- 23 Sep 2019Coming Soon…HIBCC is revamping its UDI Suite with added features and increased functionality to assist labelers in the UDI process.
- 17 Sep 2019HIBCC UDI Presentation Available for Download