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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The European Commission announces the European Medical Device Nomenclature (EMDN)
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 →
How to use HIN for Drug Supply Chain Security Act (DSCSA) requirements
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 →
European Commission releases updated EUDAMED Data Dictionary
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 →
HIBC Basic UDI-DI Guidance and Generator Now Available to Meet European Union Requirements
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 →
Important Notice to HIBCC Labelers
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 →