Coming Soon…HIBCC is revamping its UDI Suite with added features and increased functionality to assist labelers in the UDI process.

Enhanced HIBC UDI Utility The enhanced HIBC UDI Utility comes with a more intuitive design which will assist users to create UDIs faster and easier than ever. The utility automatically saves UDIs created for retrieval on the My HIBC UDI feature. Users will also have the option to create a single UDI or multiple UDIs […]

September 17, 2019

by HIBCC in Uncategorized

HIBCC UDI Presentation Available for Download

Download HIBCC UDI Presentation. Event Name: 2019 MedTech Conference / MTAA MedTech Work Shop – UDI Implementation To learn more about 2019 MedTech Conference click here. To learn more about HIBCC and UDI, visit www.hibcc.org or contact HIBCC directly at info@hibcc.org or +1 (602) 381-1091.

August 27, 2019

by HIBCC in Uncategorized

European Commission releases FAQ for Unique Device Identification System (UDI)

The European Commission published an FAQ document for implementing and satisfying the UDI System requirements set forth in the EU Medical Device Regulations 2017/745 and 2017/746. The FAQ document covers compliance dates, the Basic UDI-DI, labeling requirements, and other important information for medical device manufacturers. To view the complete FAQ document click here. To learn […]

August 26, 2019

by HIBCC in Uncategorized

HIBCC Upcoming Speaking Engagements

HIBCC will be speaking about UDI at the following meetings in September 2019. Sydney, Australia – September 18 & 19, 2019 HIBCC President Robert Hankin will be speaking on UDI implementation at the 2019 MedTech Conference, as well as leading a pre-conference workshop (attendance at the workshop is limited to MTAA members). He will focus […]

August 23, 2019

by HIBCC in Uncategorized

HIN User Account Page Enhanced to Provide Multiple Customer Identifiers

HIBCC has updated its user account page to provide HIN users with the ability to add related identifiers to their Customer HIN Lists (CHLs). The CHL was designed to allow licensed HIN users to create and manage their customer HINs without having to search and sort the entire HIN database. Each CHL is specific to […]

August 16, 2019

by HIBCC in Uncategorized

HIBCC establishes EU-MDR mailbox

HIBCC has established a new mailbox – udisupport@hibcc.eu – for inquiries and technical support related to the European Union Medical Device Regulation (MDR). The use of this mailbox will streamline requests for both new EU-MDR registrations and support for existing users.

July 26, 2019

by HIBCC in Uncategorized

EHIBCC website consolidated with HIBCC Global

The EHIBCC website, formerly www.ehibcc.com, has been consolidated with that of HIBCC Global. The European Commission has designated HIBCC to be a Unique Device Identifier (UDI) Issuing Agency as part of the European Union Medical Device Regulation (MDR), which will apply to all EU member nations. To learn more about HIBCC and UDI, visit www.hibcc.org […]

July 2, 2019

by HIBCC in Uncategorized

HIBCC Welcomes Pakistan-Based Affiliate

HIBCC is pleased to announce that it has appointed a Pakistan-Based affiliate organization, in cooperation with QMSCI (Quality Management System Certification International), a long-standing regulatory and engineering consulting company that is headquartered in Sialkot, PK and also has offices in several other countries. QMSCI has created a new organization, HIBCC Pakistan (HIBCC PK). HIBCC PK […]

June 21, 2019

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HIBCC UDI Suite Enhancements

HIBCC UDI Suite’s Calculate Check Character function has been updated to allow users to calculate multiple UDI / bar code data check characters at a time. This is a tool provided to all HIBCC Labelers. Click here to access the updated utility. Follow the instructions below to use the updated utility. 1. Enter the UDI/Bar […]

June 12, 2019

by HIBCC in Uncategorized

European Commission Designates HIBCC as an Issuing Entity for its UDI Initiative

The European Commission has designated HIBCC to be a Unique Device Identifier (UDI) Issuing Agency as part of the European Union Medical Device Regulation (MDR), which will apply to all EU member nations. HIBCC’s EU Issuing Entity designation was announced on June 7th, 2019. HIBCC has been an Issuing Agency for the U.S. FDA’s UDI […]