A Continuation of Global Endorsement
ICCBBA is pleased to announce the renewal of its designation as a Unique Device Identifier (UDI) issuing entity by the European Union, reaffirming our longstanding role in the global medical device landscape. This renewal, outlined in Commission Implementing Decision (EU) 2024/2120 of 30 July 2024, extends ICCBBA’s authority to issue UDIs within the EU for an additional five years, from 27 June 2024 until 27 June 2029. You can view the official publication in the Official Journal of the European Union (OJ L, 2024/2120, 1.8.2024) via the European Legislation Identifier (ELI): http://data.europa.eu/eli/dec_impl/2024/2120/oj.
This is not a new designation but a continuation of our existing role as one of the four UDI issuing entities, first established under Commission Implementing Decision (EU) 2019/939. The renewal reaffirms ICCBBA’s continued compliance with the stringent regulatory requirements set by the European Union and highlights our ongoing commitment to the accurate and efficient identification of medical devices that contain medical products of human origin across the European market.
Reaffirming Global Recognition
Beyond the European Union, ICCBBA continues to be endorsed by key regulatory bodies worldwide. Our role as a UDI issuing entity has already been recognized by the U.S. Food and Drug Administration (FDA), and other authorities across multiple jurisdictions. These endorsements reflect the global trust placed in ICCBBA’s ability to uphold the highest standards for medical device identification and traceability.
The renewed designation in the EU complements these ongoing relationships and solidifies ICCBBA’s role as a trusted partner in Global biovigilance, working to ensure that medical devices are properly identified and tracked for the benefit of patients.
Looking Forward
As we look ahead to the next five years, ICCBBA is proud to continue working with regulators, manufacturers, and healthcare providers to promote safe, effective, and harmonized medical device identification processes. Our ongoing designation by the European Union, alongside the U.S., Switzerland, Saudi Arabia, and other nations, underscores our dedication to maintaining the global trust that has been built over the years.
We are excited to continue this journey, ensuring that ICCBBA remains a key player in the global efforts to enhance medical device traceability, patient safety, and regulatory harmonization.
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About ICCBBA:
ICCBBA is the international standards organization responsible for the management and development of the ISBT 128 Standard.
The acronym ISBT was originally derived from the important role played by the International Society of Blood Transfusion in the development of the Standard. Today it expands as Information Standard for Blood and Transplantation. The number 128 reflects the 128 characters of the ISO/IEC 646 7-bit character set.
The acronym ICCBBA is derived from the International Council for Commonality in Blood Banking Automation.
For More Information About ICCBBA:
Media Contact: Christina Salinas
Email: support@isbt128.org
Author
Global Development Manager, ICCBBA
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