UDI Labelling for Medical Devices

Read on to learn basic knowledge of UDI, adoption advantages, and the corresponding marking methods.

 

Identifying medical devices improves safety in the medical field, including in the distribution stage. This operational system was designed to make providing optimal treatment even easier. A unique device identifier comes in two forms: device identifiers and production identifiers. Device identifiers identify the product’s name, while production identifiers are the product code, lot number, expiration date, serial number, and manufacturing date. With all this information readily available, traceability practices and anti-counterfeiting efforts are even better than before. When labelling unique device identifier, there are strict UDI requirements. The UDI must be clearly shown on a device and be readable by humans and machines.

Using a laser marker for UDI compliance guarantees that UDI medical devices follow requirements. Laser marking creates clean, high contrast, and permanent marks that withstand the UDI water test. Unlike ink, marks from a laser do not smudge, erase, or distort over time.

 

Using a UV laser, specifically KEYENCE’s 3-Axis UV Laser Marker MD-U Series, is a sure way to meet UDI requirements. This UV laser doesn’t rely on heat stress to mark and produces permanent marks that keep their initial contrast even with consistent washing. The 3-axis control of the laser autofocuses for the laser marker to mark even the most compact and odd-shaped devices. Additionally, the MD-U’s shorter wavelength leads to a smaller beam spot compared to longer wavelength lasers like Fiber or CO₂. This is key when making small and precise marks that need to be readable by machines and humans.