The European Commission released the third version of the Medical Device Coordination Group’s (MDCG) “Guidance on Basic UDI-DI and Changes to UDI-DI” document. The new version includes additional information on devices that are directly marked and the manner in which the production of the device is controlled. To view the updated guidance document click here. […]
Download the full HIBCC Presentation. Event Name: 2020 Distribution Management Conference and Expo To learn more about HIBCC and the HIN System, visit www.hibcc.org or contact HIBCC directly at info@hibcc.org or +1 (602) 381-1091.
HIBCC has consolidated its various points of contact to assure uniform compliance with the European Union and the US FDA UDI regulations, for which we have been designated as the Issuing Entity and Issuing Agency respectively. Accordingly, we have assumed all LIC assignment and maintenance responsibilities. Labelers are asked to direct their communications and inquiries […]
The European Commission announced that the European Medical Device Nomenclature (EMDN) will be the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. The EMDN is based on the Italian Classificazione Nazionale Dispositivi medici (CND). To view the European Commission statement on EMDN click here. To view the Classificazione Nazionale […]
The FDA introduced DSCSA as the federal framework to address supply chain security for prescription drugs distributed in the United States. DSCSA aims to protect consumers from counterfeit and/or contaminated drugs by aiding in the detection and removal of danger substances from the supply chain. DSCSA outlines the steps to build an electronic, interoperable system […]
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 […]
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 […]
