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Understanding Basic UDI-DI in EUDAMED

Nov 27, 2023 | Medical Devices, Unique Device Identification

By submitting product data to health authority data bases, the medical device industry can help ensure safety and traceability for devices. One crucial element is the European Commission/EUDAMED-specific concept of Basic Unique Device Identifier – Device Identifier (Basic UDI-DI). This blog will examine what Basic UDI-DI means, why it is essential, and how it plays a role in product data submissions to EUDAMED.

What is Basic UDI-DI?

Unique to the European Commission and EUDAMED, Basic UDI-DI is a product group identifier for related medical devices, like a ‘family’ of devices. The relationship is child to parent. Multiples of devices may be grouped under a family group or Basic UDI-DI. Each medical device UDI-DI has only one Basic UDI parent. All medical devices included in the Basic UDI-DI group share the same intended purpose, risk class, essential design, manufacturing characteristics, and certification. All medical devices included in the Basic UDI-DI group have the same model/group data attributes reported to the EUDAMED UDI/Device module.

The European Commission Medical Device Coordination Group (MDCG) format has specific requirements, including a maximum amount of 25 characters and the inclusion of a check digit or character. Basic UDI-DI is created by the manufacturer and issued by a medical device standards group (GS1, HIBCC, ICCBBA, IFA).

Those devices complying with MDR/IVDR regulations will have a Basic UDI-DI. Note that there is not a grouping concept for ‘legacy devices’. For EUDAMED legacy devices, the EUDAMED DI is created and is a 1:1 relationship.

Here is an example of a Basic UDI-DI grouping highlighting forceps.

Why is Basic UDI-DI Important?

Basic UDI-DI is used throughout the lifecycle of a product in the EUDAMED database. Basic UDI-DI is not used in any labeling, physical marking or GS1 AIDC data carrier (like a bar code) on associated trade items. Specific use cases include the following.

Conformity Assessments: If a device needs a Conformity Assessment (before being placed on the market) as well as EU Technical Documentation Assessment Certificate, EU Type-examination Certificate and EU Product Verification Certificates may be involved.

Manufacturer Documentation: For the EU Declaration of Conformity, Technical Documentation and Summary of Safety and Clinical Performance (if the device is a Class III or implantable device), Basic UDI-DI would be included.

Data Reporting to EUDAMED: Device Registration and submission of UDI Core Data Elements in the UDI/Device Module.

Export Devices: Basic UDI-DI is included in Certificate of Free Sale to the member state.

 For a quick introduction to the concept of EUDAMED Basic UDI-DI, see this short video.

 See an example of EUDAMED Basic UDI-DI implemented per a GS1 standard in this short video.

Questions about health authorities and Unique Device Identification (UDI)? We monitor health authorities around the globe for the latest requirements and exceptions. If you have UDI questions, we can help. Email us: [email protected] or call +1-215-557-3010