HIBCC Industry News
Although our scope has expanded beyond the initial HIBC labeling mandate issued 30 years ago, we have continued to emphasize ‘safety first’ through the years.
As such, the Health Industry Business Communication Council has an important advocacy and educational role in today’s healthcare industry. We are proud to act as the forum through which consensus can be reached as all parties work together to ensure a safer, more efficient industry.
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In December 2020, the European Commission (EC) launched EUDAMED’s Actor registration module. EUDAMED is the IT system developed by the EC to implement the EU MDR and IVDR UDI requirements. The Actor registration module is the first of six modules, which will be released in phases. The module allows economic operators to submit a request.. read more →
HIBCC has launched its redesigned iHIN Web-Based Portal (iHIN 2.0). iHIN 2.0 includes new and enhanced features designed to assist you in your daily use of the HIN Database. The beta iHIN 2.0 is now available. Although the previous version of the Portal (www.hibcchin.org) will remain available during the transition period (through November 30, 2020),.. read more →
The European Commission (EC) will make the Actor registration module of EUDAMED available to Member States and economic operators (i.e. distributors, manufacturers, authorized representatives, and importers) on December 1, 2020. The module allows economic operators to submit a request for a Single Registration Number (SRN), which will be the code used to identify a specific.. read more →
To register click here. HIBCC is designated as an Issuing Entity by both the European Commission and the US FDA for their respective UDI initiatives. To learn more about HIBCC and UDI, visit www.hibcc.org or contact HIBCC directly at firstname.lastname@example.org or +1 (602) 381-1091. read more →
The Health Industry Business Communications Council (HIBCC) is pleased to announce that its Health Industry Number (HIN) System is now available to registered HIN licensees via Chronicled’s blockchain-enabled MediLedger Network. By using Mediledger, HIN pharma industry licensees will both be able to access and use real-time HIN data and incorporate it directly into their live.. read more →
The European Commission released an updated version of their Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) Unique Device Identification (UDI) FAQ document. The original document was released in August of 2019. The revised FAQ document contains updated information on the MDR Date of Application and the deadline for submission to EUDAMED. The dates.. read more →
- 09 Jun 2021EC publishes FAQ on the European Medical Device Nomenclature
- 19 May 2021EC publishes guidance addressing MDR requirements in the event EUDAMED is not fully functional
- 25 Mar 2021Is your software considered a medical device under the EU MDR/IVDR?
- 15 Mar 2021EC publishes MDR guidance on Custom-Made Devices
- 17 Feb 2021Register now for our HIBCC EU UDI Webinar