CDRH
This blog post will provide an overview of the GUDID, its purpose, how it works, and its impact on the healthcare industry. Table of Contents The FDA’s Global Unique Device Identification (UDI) Database is a pioneering initiative that has revolutionized the...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission composed of representatives of all the EU Member States, issued guidance dedicated to the Unique Device Identification (UDI) system implemented by the Medical Device Regulation...
North America
The FDA is in the process of implementing the Unique Device Identification (UDI) System in a series of phases. Currently, all Class III and implantable, life-supporting and life-sustaining medical devices require UDIs. The next phase of the system will be implemented...
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