HIBCC has consolidated its various points of contact to assure uniform compliance with the European Union and the US FDA UDI regulations, for which we have been designated as the Issuing Entity and Issuing Agency respectively. Accordingly, we have assumed all LIC assignment and maintenance responsibilities. Labelers are asked to direct their communications and inquiries to HIBCC at firstname.lastname@example.org or email@example.com.
European labelers who have previously registered through EHIBCC should contact HIBCC at the above email addresses to confirm their information is correctly registered in our LIC/UDI registry. Please be sure to verify your contact information with HIBCC and update any changes, in order to assure that our required submissions to the EC and FDA are accurate.
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.
- 28 May 2020United Kingdom (UK) regulatory agency publishes HIBCC UDI template for use in medical device corrective action communications
- 26 May 2020FDA UDI labeling and database submission deadline for Class I and unclassified devices rapidly approaching.
- 29 Apr 2020European Commission publishes guidance document on regulatory requirements for ventilators
- 15 Apr 2020Chronicled’s Mediledger utilizing the HIBCC HIN identifier for Contracting and Chargebacks in its’ blockchain network
- 15 Apr 2020HINAPI is now available