What's difference between the Basic UDI-DIs and UDI-DIs ?

In the context of the European Union Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (IVDR), understanding the hierarchy of identification is crucial for compliance.

While they sound similar, the Basic UDI-DI and the UDI-DI serve different levels of the product lifecycle.

1. Basic UDI-DI (The "Family" Identifier)

The Basic UDI-DI is the main key in the EUDAMED database and relevant documentation. It identifies a product device group (a "family") with the same intended purpose, risk class, and essential design characteristics.

• Where it appears: It is used in administrative and legal documents such as the Certificate of Conformity, Technical Documentation, Summary of Safety and Clinical Performance (SSCP), and the EU Declaration of Conformity.
• Key Characteristic: It is never printed on the physical product label or the packaging.
• Purpose: It links different product variants back to a single regulatory record.

2. UDI-DI (The "Product" Identifier) 

The UDI-DI (Device Identifier) is a unique numeric or alphanumeric code specific to a model or version of a device. It is the "static" part of the UDI that identifies the specific product configuration.

• Where it appears: It is printed on the device label or its packaging (as part of the UDI carrier, along with the UDI-PI/Production Identifier like batch numbers).
• Key Characteristic: If you change the design, the package size, or the quantity in a box, a new UDI-DI is usually required.
• Purpose: It is used for supply chain traceability, scanning at hospitals, and identifying the specific item in the market.

Key Differences at a Glance：

Why are they useful?

• Regulatory Efficiency: Regulators can track entire product families (Basic UDI-DI) rather than looking at thousands of individual SKU variations (UDI-DI) when reviewing safety data.
• Market Surveillance: If a specific model has a defect, the UDI-DI allows hospitals to identify exactly which boxes to pull from the shelf.
• Transparency: Through the EUDAMED database, the public and healthcare professionals can see the relationship between a specific device in their hand and its overarching regulatory certifications.