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 (EC) released an FAQ document on the European Medical Device Nomenclature (EMDN). The EMDN is intended to support the functioning of EUDAMED and will be utilized during the UDI/Devices Registration Module. The UDI/Devices Registration Module is projected to be available to manufacturers beginning in September of 2021 (previously May 2021). To view […]
The European Commission (EC) released a guidance on the application and implementation of certain provisions in the Medical Device Regulation (MDR) in the absence of EUDAMED. This guidance “intends to describe harmonised administrative practices and alternative technical solutions for the exchange of information until EUDAMED becomes fully functional.” In 2019 the EC announced that the […]
In March 2021 the European Commission released an infographic to assist manufacturers in determining whether their software qualifies as Medical Device Software (MDSW). The EU MDR definition of MDSW is “software that is intended to be used, alone or in combination, for a purpose as specifiedin the definition of a “medical device” in the MDR […]
In March 2021 the European Commission published a guidance document titled “Questions and Answers on Custom-Made Devices”. The document includes high-level information “aimed at addressing the most pertinent questions relating to custom-made devices falling under the MDR”. To view the guidance on Custom-Made Devices click here. To learn more about HIBCC and UDI, visit www.hibcc.eu or contact […]
The European Union’s Medical Device Regulation requires all Basic UDI-DIs and UDIs to be assigned by May 2021. Register for the HIBCC webinar to learn more. To register click here. HIBCC is designated as an Issuing Entity by both the European Commission and the US FDA for their respective UDI initiatives. To learn more about […]
To register click here. HIBCC is designated as an Issuing Entity by both the European Commission and the US FDA for their respective UDI initiatives. To learn more about HIBCC and UDI, visit www.hibcc.org or contact HIBCC directly at info@hibcc.org or +1 (602) 381-1091.
In December 2020, the European Commission (EC) launched EUDAMED’s Actor registration module. EUDAMED is the IT system developed by the EC to implement the EU MDR and IVDR UDI requirements. The Actor registration module is the first of six modules, which will be released in phases. The module allows economic operators to submit a request […]
HIBCC has launched its redesigned iHIN Web-Based Portal (iHIN 2.0). iHIN 2.0 includes new and enhanced features designed to assist you in your daily use of the HIN Database. The beta iHIN 2.0 is now available. Although the previous version of the Portal (www.hibcchin.org) will remain available during the transition period (through November 30, 2020), […]
The European Commission (EC) will make the Actor registration module of EUDAMED available to Member States and economic operators (i.e. distributors, manufacturers, authorized representatives, and importers) on December 1, 2020. The module allows economic operators to submit a request for a Single Registration Number (SRN), which will be the code used to identify a specific […]
