The Unique Device Identifier (UDI) is a system implemented under the In Vitro Diagnostic Regulation (IVD-R) from the European Union that assigns a unique specific alphanumeric code to each type of medical device.

Each UDI is made up of two parts: the Device Identifier (DI), which is specific to the device model and the manufacturer, and the Production Identifier (PI), which includes the device's production information such as its lot number, serial number, and expiration date.

The UDI system is used for several important purposes:

1. Improve traceability: UDIs enable better tracking of devices throughout their lifecycle, improving the ability to trace devices in the event of a recall or safety concern.
2. Enhance patient safety: The system allows healthcare providers to more accurately report adverse events, helping to quickly identify and address safety issues.
3. Facilitate device identification: It simplifies the process of identifying a device's make, model, and important characteristics.

The advantages of implementing the UDI system are anticipated to be:

1. Improved post-market surveillance: The UDI can help regulators better monitor the performance and safety of devices after they have been brought to market.
2. Streamlined inventory management: The system can also assist healthcare providers in managing their inventory more efficiently.
3. Enhanced data quality: The UDI system standardizes and improves the quality of data associated with medical devices.

Our roadmap for UDI implementation:

1. We start with class D CE approved products for blood grouping in the year 2023. (hence the addition of the suffix “.X” to the Anti-A, Anti-B, Anti-AB and Anti-D with CE mark.
2. In 2025 we will roll out the UDI for class C IVD’s.
3. In 2026 we will roll out the UDI for the remaining IVD’s in our product range

Obviously, the roll-out timeline is subject to adjustments. We will keep you updated!