The European Commission released a Question and Answer document containing information on the required procedures and standards for manufacturers of PPE (Personal Protective Equipment). The document will be updated on a regular basis in order to address additional questions and concerns. To view the document click here. HIBCC is designated as an Issuing Entity by […]
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.
MedTech, the European trade association for the medical technology industry, published a document to provide guidance on the assignment of Basic UDI-DIs. The Basic UDI-DI is a required element of the EU Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR). The Basic UDI-DI will be included in the EU’s EUDAMED database and is referenced […]
The UK Medicines & Healthcare Products Regulatory Agency (MHRA) utilizes global UDI standards to communicate device safety information and corrective actions. Manufacturers are required to send Field Safety Notices (FSNs) and Field Safety Corrective Actions (FSCAs) to device users. MHRA “considers it best practice to include unique device identifiers (UDIs) in field safety corrective action […]
The US FDA UDI compliance deadline for Class I and unclassified devices is September 24, 2020. All labels and packages of all Class I and unclassified devices must bear a UDI , and the UDI must be submitted to the FDA’s Global UDI Database (GUDID) by the compliance deadline. To view the FDA UDI compliance […]
Due to the global COVID-19 pandemic and the increased need for ventilators, the European Commission has published a guidance document on the regulatory requirements for ventilators and related accessories. The document “outlines the different regulatory options for placing these devices on the EU market indicating their feasibility to allow short term supply.” To view the […]
Chronicled is building an open, decentralized network, called the MediLedger Network , in response to the FDA’s Drug Security Supply Chain Act (DSCSA). The MediLedger Network will streamline communication and transactions between all trading partners. An important aspect of DSCSA and the MediLedger Network is identifying customers and their locations, and the HIN will serve […]
HIBCC’s HIN Application Programming Interface (HINAPI) Service is now available. The HINAPI provides real-time HIN database integration with existing user systems and applications. HIBCC’s HIN System is an integral part of the healthcare supply chain, and its expanding use has created the need for our licensees to be able to access and utilize HIN data […]
HIBCC will shortly offer its HIN Application Programming Interface (HINAPI) Service to provide real-time HIN database integration with existing user systems and applications. HIBCC’s HIN System is an integral part of the healthcare supply chain, and its expanding use has created the need for our licensees to be able to access and utilize HIN data […]
HIBCC is working with the US DoD Defense Logistics Agency (DLA) Troop Support to expedite Health Industry Number (HIN) requests and updates. The DLA is a long-time HIN user, and as it ramps up support of the COVID-19 relief effort, HIBCC has provided new HIN assignments for the DLA. For example, HIBCC has recently created […]
