UDI
Definition
Unique Device Identifier. A code mandated by the FDA (US) and EU MDR on every medical device, encoding manufacturer, model, lot and serial number. The basis for tracing a recovered surgical implant through the supply chain to the hospital record and the patient.
- Full name
- Unique Device Identifier
- Mandated by
- FDA (US) and EU MDR
- Encodes
- Manufacturer, model, lot, serial number
- Applies to
- Medical devices, including implants
Common questions
How does a UDI help identify unknown human remains recovered with a surgical implant?+
Reading the UDI code from the implant, or from an x-ray if it is radio-opaque, lets investigators trace the device through the manufacturer's distribution records to the hospital and surgical record it was implanted under, which can lead directly to the patient's identity.
What limits UDI-based identification for older implants?+
UDI mandates are relatively recent regulatory requirements, so implants placed before the applicable compliance date may lack a UDI entirely, leaving investigators to rely on older methods such as manufacturer part-number lookup or radiographic comparison instead.
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