Glossary›UDI
UDI
Unique Device Identification: the unique identifier for medical devices under the European Medical Device Regulation. It appears on the pack and in the EUDAMED database.
What it means
A UDI has two parts. The device identifier (UDI-DI) names the model and the packaging level and is usually a GTIN. The production identifier (UDI-PI) holds the batch or serial number and the manufacturing and expiry dates. Both appear in plain text and as a barcode or Datamatrix on the label.
Manufacturers must register the UDI-DI in EUDAMED. Healthcare facilities and distributors use the UDI to trace a product back to its batch.
Why it matters in procurement
In a recall or a complaint it must be clear which batch sits in which facility. The UDI makes that possible without searching. It links the article in the purchasing system to the product on the shelf and to the entry in the register.
How SANOVIO works with it
SANOVIO records the UDI on the article and on the batch. It is checked at batch release, and in logistics it accompanies every delivery into the facility.