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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Register now for our second HIBCC UDI Webinar
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. read more →
EC releases conformity assessment procedures for manufacturers of protective equipment
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.. read more →
Register now for our HIBCC UDI Webinar
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. read more →
MedTech Europe releases guidance on Basic UDI-DI assignment for the EU MDR
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.. read more →
United Kingdom (UK) regulatory agency publishes HIBCC UDI template for use in medical device corrective action communications
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.. read more →
FDA UDI labeling and database submission deadline for Class I and unclassified devices rapidly approaching.
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.. read more →