Unique Device Identification (UDI)

A series of numeric or alphanumeric characters generated through an internationally accepted device identification and coding standard. It allows the identification of a particular device on the market in a way that does not allow for ambiguity.

UDI consists of UDI-DI and UDI-PI.

• Device identifier (UDI-DI)
• Manufacturing identifier (UDI-PI)

UDI Description: Unique device identification = Unique device identification = Unique device identifier
UDI = UDI DI + UDI PI

UDI, which can be translated as Unique Identification Number, comes with the new EU MDR 2017/745 and IVDR 2017/746 in the USA as well as in Europe. It is one of the new requirements.

Within the EU, the manufacturer will assign a Basic UDI-DI to its devices along with a UDI, which will be the key to the traceability of devices in Europe. It is a system used by the FDA.

• Ensuring rapid data exchange between the competent authorities regarding after-market activities
• Fighting against fraud and smuggling
• Monitoring the distribution channel
• Stock control