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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HIBCC Announces HIN Data integration within the MediLedger Network

September 14, 2020
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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 →

EC releases updated MDR / IVDR UDI FAQs

August 18, 2020
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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 →

Register now for our second HIBCC UDI Webinar

July 28, 2020
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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 releases conformity assessment procedures for manufacturers of protective equipment

July 27, 2020
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The European Commission released a Question and Answer document containing information on the required procedures and standards for manufacturers of PPE (Personal Protective Equipment). The document will be updated on a regular basis in order to address additional questions and concerns. To view the document click here. HIBCC is designated as an Issuing Entity by.. read more →

Register now for our HIBCC UDI Webinar

June 15, 2020
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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 →

MedTech Europe releases guidance on Basic UDI-DI assignment for the EU MDR

June 3, 2020
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MedTech, the European trade association for the medical technology industry, published a document to provide guidance on the assignment of Basic UDI-DIs. The Basic UDI-DI is a required element of the EU Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR). The Basic UDI-DI will be included in the EU’s EUDAMED database and is referenced.. read more →