UDI DI Number in Medical Devices
The UDI is a series of numeric or alphanumeric characters created through a globally accepted device identification and coding standard. It allows identification of a medical device on the market. The UDI comprises of UDI-DI and UDI-PI.
- A UDI device identifier (‘UDI-DI’) is specific to a device, providing access to the information laid down in Part B of Annex VI.
- A UDI production identifier (‘UDI-PI’) identifies the unit of device production and if applicable the packaged devices, as specified in Part C of Annex V.
- The placing of the UDI carrier on the label of the device or on its packaging or in case of reusable devices on the device itself (direct marking).
- The Basic UDI-DI in the Eudamed database is the main key access for device-related information. Details of Basic UDI-DI are mentioned in Technical documents such as Free sale certificate, EU declaration of conformity, technical documentation and summary of safety and clinical performance.
- It is intended to identify and connect devices with the same intended purpose, risk class, design and manufacturing characteristics.
- It is independent from the packaging/labelling of the device and it does not appear on any trade item.
- Any Basic UDI-DI shall identify the devices (group) covered by that Basic UDI-DI in a unique manner.
- The UDI Shall be used for reporting serious incidents and filed corrective action in accordance with article 87 of EU MDR 2017/745 & article 82 of EU IVDR 2017/746.