GTIN and UDI Caught in the Trap of Distribution Branding
GTIN codes and UDI system were intended to provide complete traceability. However, a gray area prevailed and large distributors assigned their own UDI-DI codes through issuing entities. The long-awaited MDCG 2026-5 document, in conjunction with Annex VI of the MDR, finally puts an end to the speculation. Who is legally responsible for assigning UDIs, what obligations apply to repackagers under Article 16, and where do we encounter unresolved legislative pitfalls when downsizing packaging?