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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.
The unique device identifier includes the following:
*Source: https://health.ec.europa.eu
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
The EU. and U.S. regulations require all devices and packaging levels (with some exceptions) to include a UDI.
*Source: https://www.rimsys.io
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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