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These regulations are designed to increase traceability of devices placed on the market. Additional content needs to be included on device packaging and labeling including a Unique Device Identifier (UDI) in the form of a 2D matrix to be scanned at various points across the supply chain, and an anti-tamper device. Kallik makes it easier to stay compliant with current and future regulations which impact pharmaceutical packaging and labeling.

How does Kallik help with EU FMD?

Kallik helps medical device manufacturers ensure their products are correctly labeled in accordance with both the EU FMD and global serialization requirements for device identification, manufacturer, safety and re-use requirements.



• Improves transparency and traceability by managing all fixed and variable product and production data within one global platform.


• Establishes a single source of labeling ‘truth’ that all market-facing product information and materials flow from


• Increases vigilance of label layouts and content and ensures messaging is aligned across increasingly diverse product portfolios and distribution channels

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