Understanding UDI-DI vs. Basic UDI-DI: A Breakdown of Unique Device Identification

By Shen May Khoo, Junior Regulatory Specialist at Mantra Systems Ltd.

With the implementation of the European Union’s Medical Device Regulations (MDR) 2017/745 and In Vitro Diagnostic Regulations (IVDR) 2017/746, a new Unique Device Identification (UDI) system has been introduced to enhance the traceability and safety of medical devices across the EU. A key part of this system involves the assignment of both UDI-DI and Basic UDI-DI to medical devices. Understanding the distinction between these two identifiers is critical for manufacturers, economic operators, and healthcare institutions.?

What is UDI-DI??

The UDI-DI (Unique Device Identifier-Device Identifier) is a specific, unique identifier that corresponds to a particular medical device. It is designed to provide access to important information about the device, such as its manufacturer, model, and key characteristics. The UDI-DI is a permanent identifier for the device and is required to appear on the device's label or packaging.?

A UDI-DI must be assigned by the manufacturer before the device is placed on the market, and it must be included in the European Database on Medical Devices (EUDAMED). The UDI-DI ensures that every medical device can be accurately traced, improving patient safety by enabling quick responses in case of recalls or adverse events.?

What is Basic UDI-DI??

The Basic UDI-DI, on the other hand, is a broader identifier used to group devices with the same intended purpose, risk class, and essential design characteristics. It serves as the primary access key for device-related information in the EUDAMED database and is referenced in key documentation such as certificates, declarations of conformity, and technical documentation.?

Unlike the UDI-DI, the Basic UDI-DI does not appear on the packaging or label of the device. Instead, it links together devices that share similar characteristics but may be distributed in different configurations or packaging sizes. The Basic UDI-DI is essential for identifying product families or groups of devices rather than individual products.?

Key Differences?

Why Both UDI-DI and Basic UDI-DI are Important?

The UDI-DI provides granular traceability for individual devices, which is vital for patient safety and regulatory oversight. It ensures that every specific product can be tracked throughout its lifecycle. The Basic UDI-DI, on the other hand, simplifies the management of related products by grouping them under a common identifier in the regulatory system. This allows regulators and manufacturers to easily reference and manage device groups in the EUDAMED database.?

Conclusion?

Both UDI-DI and Basic UDI-DI play critical roles in the EU’s enhanced regulatory framework for medical devices. For manufacturers, understanding and correctly implementing both identifiers is essential for compliance with MDR and IVDR regulations, contributing to the overall safety and efficiency of medical device monitoring in the EU.?

For further guidance on UDI implementation, refer to MDCG 2018-1 Rev. 4, which provides comprehensive instructions on the UDI system under MDR and IVDR. Additionally, MDCG 2022-7 addresses frequently asked questions related to UDI and clarifies key aspects of the regulatory framework.?

If you have any questions about this article or would like to learn how Mantra Systems can support your MDR compliance, please email us at [email protected].?