The HIBC Basic UDI-DI satisfies the Basic UDI-DI requirements in the European Union’s Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR). The HIBC Basic UDI-DI enables manufacturers to connect and identify devices with the same intended purpose, risk class and essential design and manufacturing characteristics. The Basic UDI-DI is required in the EU’s EUDAMED […]
Organizations applying for a HIBCC Labeler Identification Code (LIC) are required to complete the authorized application form on this website. This requirement is for quality control purposes and to assure the labeler information that we provide to regulatory authorities is accurate and derived from the original applicant. LIC application information obtained indirectly from other sources […]
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 […]
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 […]
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 […]
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 info@hibcc.org or +1 (602) 381-1091.
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 […]
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.
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 […]
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 […]
