The HIBC UDI-Builder is now available. This tool will allow you to create, calculate, confirm, and collect UDIs.
Create HIBC UDIsThe HIBC UDI-Builder’s intuitive, easy-to-use design assists users in quickly creating their UDIs. This on line utility will generate a UDI from the product information you enter. In combination with your HIBCC LIC the Creator tool will provide you with the correct data format for printing on packages and to meet FDA-required uploads.. read more →
European Union Medical Device Coordination Group (MDCG) releases document concerning the validity of existing certificates
Devices with existing certificates will remain valid until May 27, 2024. However, there are specific conditions that existing certificates, and the related devices, must comply with. The MDCG has released a document that outlines these conditions. To view the full document click here. To learn more about HIBCC and UDI, visit www.hibcc.eu or contact HIBCC directly.. read more →
Download HIBCC UDI Presentation. Event Name: 10th China International Medical Device Regulatory Forum (CIMDR) To learn more about CIMDR click here. 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 →
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.. read more →
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 email@example.com or +1 (602) 381-1091. read more →
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.. read more →
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.. read more →
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.. read more →
HIBCC has established a new mailbox – firstname.lastname@example.org – 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. read more →
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.. read more →