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.. read more →
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.. read more →
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.. read more →
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 →