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 Jul 2020Register now for our second HIBCC UDI Webinar
- 27 Jul 2020EC releases conformity assessment procedures for manufacturers of protective equipment
- 15 Jun 2020Register now for our HIBCC UDI Webinar
- 03 Jun 2020MedTech Europe releases guidance on Basic UDI-DI assignment for the EU MDR
- 28 May 2020United Kingdom (UK) regulatory agency publishes HIBCC UDI template for use in medical device corrective action communications