Unique Device Identifikation (UDI).
On May 26, 2025, another part of the MDR (Medical Device Regulation) will come into effect1. This concerns the so-called direct marking, also known as Unique Device Identification (UDI) or data matrix.
All medical devices that are reprocessable for patient reuse must have a direct marking. Many products already meet this requirement today through a serial number on the product. All other products will comply with this requirement by the end of May 2025 with a unique product identifier.
From May 26, 2025, all reprocessable masks from Löwenstein Medical Technology Technology Technology will feature a corresponding direct marking.
A Unique Device Identification (UDI) is a standardized identification system primarily used for medical devices. It was developed to enhance patient safety by enabling clear and unambiguous identification of these products on the market and facilitating their traceability.
A serial number is a unique identifier. However, not every product will have a serial number in the future. There will still be products with a lot number (LOT number), such as masks. A lot can vary in size — at Löwenstein Medical Technology Technology, between 40 and 300 units. This lot number will continue to appear on the packaging label as “LOT” and is also included in the UDI.
Therefore, all items produced within the same lot will have the same UDI.
A UDI consists of two main components:
- Device Identifier (UDI-DI): The fixed part of the code that identifies the manufacturer and the specific version or model of a device (GTIN = Global Trade Item Number).
- Production Identifier (UDI-PI): The variable part of the code that includes information such as the lot or batch number, serial number, Service Life, or manufacturing date.
The UDI is an addition, not a replacement, to existing labeling requirements for medical devices.
For masks, the UDI is composed as follows: UDI = (01) GTIN + (17) Service Life + (10) LOT
The 1D barcode (linear barcode) is already shown on the packaging label:
New addition: A 2D barcode (data matrix) will be displayed on the product itself:
Detailed Information:
For the machine-readable component of the UDI, Löwenstein Medical Technology Technology uses the GS1 DataMatrix 2D barcode. The data in the GS1 DataMatrix image is encoded using the full GS1 encoding system, with Application Identifiers (AIs) used to separate the individual parameters.
A UDI-compliant marking must be applied directly to the medical device itself if it can be reprocessed between uses (e.g., between patients in a clinic). This involves direct marking on the medical device (e.g., via laser engraving).
The laser marking applies a machine-readable code directly to the mask body. This includes both the fixed and variable parts of the code (mask variant, Service Life, LOT), ensuring traceability of the mask.
This affects masks manufactured by Löwenstein Medical Technology in the areas of sleep and ventilation.
A 2D code-readable scanner is required.
To scan the code quickly and reliably, a high-contrast, light background is needed directly behind the marking (e.g., white paper, finger). Reflections from direct light sources on the code surface should be avoided.
The regulation comes into effect on May 26, 2025. This means all masks placed on the market by Löwenstein Medical Technology from this date onward will have a data matrix code on the mask body.