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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European Commission confirms two year delay for the launch of EUDAMED. Labeling deadlines are not affected by this delay.
The European Commission announced that EUDAMED’s launch will be done together for medical and in-vitro devices, at the original date for the in-vitro medical devices, May 2022. Previously EUDAMED was planned to launch in May 2020 for medical devices. The date of application of the Medical Device Regulation (MDR) remains May 2020. To view the.. read more →
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 →
- 27 Jan 2020Notice to Labelers: HIBCC Contact Information
- 14 Jan 2020The European Commission announces the European Medical Device Nomenclature (EMDN)
- 17 Dec 2019How to use HIN for Drug Supply Chain Security Act (DSCSA) requirements
- 04 Dec 2019European Commission releases updated EUDAMED Data Dictionary
- 05 Nov 2019HIBC Basic UDI-DI Guidance and Generator Now Available to Meet European Union Requirements