HIBCC Industry News

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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EC publishes MDR guidance on Custom-Made Devices

March 15, 2021
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In March 2021 the European Commission published a guidance document titled “Questions and Answers on Custom-Made Devices”. The document includes high-level information “aimed at addressing the most pertinent questions relating to custom-made devices falling under the MDR”. To view the guidance on Custom-Made Devices click here. To learn more about HIBCC and UDI, visit www.hibcc.eu or contact.. read more →

EC publishes guidance addressing MDR requirements in the event EUDAMED is not fully functional

March 1, 2021
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The European Commission (EC) released a guidance on the application and implementation of certain provisions in the Medical Device Regulation (MDR) in the absence of EUDAMED. This guidance “intends to describe harmonised administrative practices and alternative technical solutions for the exchange of information until EUDAMED becomes fully functional.” In 2019 the EC announced that the.. read more →

Register now for our HIBCC EU UDI Webinar

February 17, 2021
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The European Union’s Medical Device Regulation requires all Basic UDI-DIs and UDIs to be assigned by May 2021. Register for the HIBCC webinar to learn 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.. read more →

Register now for our HIBCC UDI Webinar

January 11, 2021
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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 info@hibcc.org or +1 (602) 381-1091. read more →

EC’s EUDAMED Actor registration module is now available

January 5, 2021
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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’s new iHIN Web-Based Portal now available

October 30, 2020
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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 →