UDI : FDA versus EU with CND taking center stage than GMDN

With increasing concerns for patient safety and efficient supply chain management, a single, globally harmonized identification system for medical devices is needed. Companies marketing in USA are very familiar with UDI medical devices across its distribution channel.

In the last two decades there has been a shift in the approach to evaluating the benefit-risk (BR) profiles of products from an unstructured, subjective, and inconsistent, to a more structured and objective process.