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European Union Medical Device Regulation (EU MDR) Labeling

EU MDR Labeling Software

Easily create and print EU MDR-compliant labels

 

  • CODESOFT for EU MDR label creation
    • Health Industry Barcode (HIBC) and GS1 Databar barcode creation
    • Easy-to-use wizards
    • Create user rights and enable label security controls
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  • TEKLYNX CENTRAL CFR for Label Management
    • Pull label elements from a centralized database for EU MDR-compliant labels
    • Automate labeling process with central management to ensure process enforcement and additional control
    LEARN MORE

TEKLYNX CENTRAL: bioMérieux Centralizes Biotechnology Labeling

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About EU MDR

Organizations distributing medical devices throughout the EU must comply with the EU MDR regulation established in May 2017.

 

The EU MDR is designed to ensure public health and patient safety across Europe and to increase quality and transparency of medical devices in the healthcare supply chain through label design, label approval, and label tracking standardization.

 

As a result, all medical device labels, with the exception of custom-made and performance study/investigational devices, will need to bear a Unique Device Identifier (UDI), which includes a Device Identifier (DI), Product Identifier (PI) and Human Readable Information (HRI). Medical device manufacturers and distributors across Europe must adhere to EU MDR labeling standards.

 

Compliance with EU MDR includes:

 

 

EU MDR LABEL SAMPLE

"TEKLYNX CENTRAL has improved labeling efficiency and accuracy for our entire labeling process."

- Jérôme Foltz, bioMérieux

Life Sciences Labeling & Compliance

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Creating GS1 Barcodes in CODESOFT and LABELVIEW

 

Learn how to use the GS1 barcode wizard in CODESOFT and LABELVIEW to create GS1 compliant barcodes.

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Need help complying with EU MDR?

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