What is a Unique Device Identifier (UDI)?
Unique Device Identifier Definition
A unique device identifier (UDI) is a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market. The main goal of the UDI is to improve traceability of medical devices and facilitate monitoring by applicable authorities. A UDI will be mandatory for medical devices subject to MDR 2017/745 and IVDR 2017/746, except for custom-made and performance study/investigational devices. The UDI database is integrated with EUDAMED and managed by the European Commission.
FAQs
What is included in the unique device identifier?
The unique device identifier includes the following:
- Device identifier that is specific to the device
- Production identifier that identifies the unit of device production
- Expiration date
- Lot number
- Serial number
*Source: https://health.ec.europa.eu
What is UDI used for?
A UDI enables greater traceability of medical devices, enhances post-market activities related to device safety, and allows for better monitoring by competent authorities.
*Source: https://health.ec.europa.eu
Do I need a UDI?
The EU. and U.S. regulations require all devices and packaging levels (with some exceptions) to include a UDI.
*Source: https://www.rimsys.io
How do I find my UDI number?
The UDI should appear on the device label, packaging, or on the device itself (in the case of reusable devices).
*Source: https://health.ec.europa.eu
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