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.
This paper focuses mainly on devices that manufactures have in USA and EU
- Ensure to register and update codes with Eudamed and GUDID in UDI part
- Ensure to check codes as per GMDN, WHO/CND codes
- Ensure to check device nomenclature codes for EC, FDA and other regulatory authorities approved devices
EU’s MDR & IVDR regulations and MDCG recommendations, GMDN code system will map to Italian CND codes for ease of use in EUDAMED by manufacturers or responsible personals.Once the mapping of the CND nomenclature to the GMDN nomenclature has been done, manufacturers can update device master data to reflect the new codes.
