The full UDI lifecycle – everything from a single source

BASEL CITY, Switzerland - Sept. 19, 2025 - PRLog -- he path to full UDI compliance can be understood as a data cycle: UDI master data → traceability → vigilance. Each building block matters, but only their interaction creates tangible value for manufacturers, authorities, and patients.

It starts with the registration of UDI master data with the competent authorities (GUDID, EUDAMED, swissdamed, etc.). This includes the UDI-DI (e.g., GTIN under GS1), the Basic UDI-DI (EU), and the UDI-PI (e.g., lot/serial, manufacturing/expiry date). These data are validated, versioned, and submitted to the respective registries—forming the foundation for transparency, market access, and consistent labeling/packaging hierarchies.

On this basis comes product traceability. Only when master data and GTIN are seamlessly linked can products be uniquely identified across their lifecycle—from goods receipt to point of care. This bridge ensures that regulatory requirements are not only fulfilled on paper but also work in day-to-day operations.

If an incident occurs—such as an adverse event or a recall—the cycle closes. Via systems like eMDR https://www.europe-it-consulting.ch/emdr-data-submission/... or ICSR-based reports, data are transmitted securely and in compliance to the authorities. This is where the true value of the upstream processes becomes clear: only well-governed master data and clean traceability enable fast, error-free reporting.

Our approach covers the entire UDI lifecycle and translates it into proven, ready-to-use solutions.

• For initial master-data registration, customers maintain UDI data centrally via our Global UDI Add-on https://www.europe-it-consulting.ch/global-udi-data-manag... or a UDI Excel Template, validate them rule-based, and submit to UDI authorities worldwide.
• For traceability, we provide integration components that forward manufacturing information, serial/lot movements, and sales directly from the ERP to government track-and-trace systems—for example ÜTS (Ürün Takip Sistemi) in Turkey.
• For vigilance, incidents can be transmitted as bundled submissions using our Excel eMDR template or directly from SAP Fiori, to the competent national authorities.