Unreadable or misread barcodes can lead to costly consequences: shipment delays, product recalls, lost deliveries, and risks to patient safety. For medical device manufacturers, ensuring barcode durability is more than a technical detail; it's a regulatory obligation and a clinical safeguard. Yet testing is often left too late, increasing costs, compromising timelines, and threatening compliance with Unique Device Identification (UDI) regulations. Often teams are unaware that every part of a package may require a verified, resilient label.

Eurofins Medical Device Services network of laboratories navigates these risks with confidence. Our speed and precision avoids project delays and unplanned costs. We assess the resilience of your labels to mechanical wear, shipping stress, and environmental exposure using advanced techniques. Our label durability testing services ensure that all markings on your packaging withstand the real-world conditions your products face, helping you meet regulations, reduce cost, and protect patient health. Our scientists perform durability and barcode scannability assessments in line with globally recognised standards including:

• ISO/IEC 15415, 15416
• ISO/IEC 15426-1, 15426-2
• ISO/IEC TR 29158 (DPM Cat 0)

Our cGMP-compliant laboratories use verification systems with an active field of view of up to 6.25" (159 mm) and can support nearly all 1D and 2D symbologies. Every report details each conformance attribute, allowing quick identification of issues and easy corrective actions.

Eurofins Medical Device Services supports you throughout your device’s lifecycle, from the selection of appropriate labelling methods to post-validation stress testing. If you’re introducing new packaging, changing suppliers, or scaling up production, our services are designed to ensure repeatability, reliability, and compliance with evolving UDI frameworks.