The European Commission released version 5.0 of the EUDAMED Data Dictionary. This document provides an overview of the data fields and corresponding definitions that are to be provided to Eudamed and that can be communicated through the Data Exchange process for the UDI/Device module. To view the the EUDAMED Data Dictionary V5.0 click here. To.. read more →
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.. read more →
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.. read more →
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 email@example.com 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 firstname.lastname@example.org 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 →