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 […]
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.
The Health Industry Business Communications Council (HIBCC) is pleased to announce that its Health Industry Number (HIN) System is now available to registered HIN licensees via Chronicled’s blockchain-enabled MediLedger Network. By using Mediledger, HIN pharma industry licensees will both be able to access and use real-time HIN data and incorporate it directly into their live […]
The European Commission released an updated version of their Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) Unique Device Identification (UDI) FAQ document. The original document was released in August of 2019. The revised FAQ document contains updated information on the MDR Date of Application and the deadline for submission to EUDAMED. The dates […]
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.
