EC publishes dedicated webpage on EUDAMED Actor registration module

October 22, 2020
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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.. read more →

Register now for our HIBCC UDI Webinar

October 7, 2020
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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 →

HIBCC Announces HIN Data integration within the MediLedger Network

September 14, 2020
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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.. read more →

EC releases updated MDR / IVDR UDI FAQs

August 18, 2020
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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.. read more →

Register now for our second HIBCC UDI Webinar

July 28, 2020
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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

July 27, 2020
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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

June 15, 2020
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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

June 3, 2020
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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

May 28, 2020
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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.

May 26, 2020
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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 →