EU MDR Compliance

The EU- MDR establishes an equivalent to the Unique Device Identifier (UDI) system developed by the United States Food and Drug Administration (FDA). Companies whose products are distributed in the European Union must comply with the MDR.

The EU MDR also utilizes UDI to facilitate the traceability of medical devices. Each has a device identifier (DI) specific to manufacturer and device and a production identifier (PI) that identifies the device’s production unit and includes serial number, lot/batch number, software identification and/or manufacturing and/or expiration date. This will enable products to be traced through the supply chain from manufacturer to final use. 

Read the final version of the European Medical Device Regulation here

Download our white paper to learn more

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Complimentary webinar

Label Compliance and the New European Medical Device Regulations (MDR)

Learn what medical device manufacturers need to do to prepare for compliance, the benefits of implementing a label management system and how label verification and print quality inspection aid compliance.

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Compliance that reduces operating costs

NiceLabel’s next generation label management system helps you comply with EU MDR regulations while transforming your labeling processes to deliver real business value.

  • Consolidate labeling systems and processes
    Maintaining multiple labeling systems is expensive, not to mention time consuming. Disparate systems can produce label variations and inaccuracies. Standardize on a single platform for labeling that integrates with core business systems to streamline the entire labeling process.
  • Empower business users
    Having business users create label templates using a simple, Microsoft Word-like user interface means that costly IT resources can focus on other mission critical projects.
  • Eliminate errors and mitigate risk
    Label errors are costly mistakes considering they are one of the main causes of medical device recalls. Modern label management eliminates the need for error prone manual labeling and establishes a secure and controlled label design and approval process.
  • Streamline your supply chain
    Establish consistent labeling processes across all manufacturing sites to transform the supply chain and eliminate the need for costly, separate labeling operations at each location.

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More about EU MDR, UDI and related topics

Blog post

European Medical Device Directives – How a small-medium sized medical device company responded to the new regulations

Read more

Blog post

Validation of increasing importance for life sciences companies

Read more

Adopting Next Generation Labeling Technology Enhances Enterprise Agility and Reduces Costs

White paper

Adopting Next Generation Labeling Technology Enhances Enterprise Agility and Reduces Costs

Download white paper

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