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Summary

The Device Label is a regulatory-compliant information display that contains all required identification, safety, and regulatory information for your medical device software. This label must be accessible within your software interface and includes essential elements like CE marking, UDI information, manufacturer details, and safety warnings required for market access and regulatory compliance.

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Why is Device Label important?

Device labeling is legally mandated for all medical devices and serves as the primary source of identification and safety information for users and regulatory authorities. The label ensures traceability throughout the device lifecycle and provides critical information that healthcare providers need to use your device safely and effectively. For software medical devices, the label must be electronically accessible and contain all the same regulatory information required for physical devices, demonstrating compliance with labeling regulations and enabling proper device identification in clinical settings.

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Regulatory Context

Under 21 CFR Part 801 (Labeling):

  • Device identification (801.1) requires clear device identification and manufacturer information
  • Labeling requirements (801.15) mandate specific information display
  • Software labeling guidance requires electronic accessibility of label information
  • UDI requirements (801 Subpart B) mandate unique device identification

Special attention required for:

  • Software version identification and traceability requirements
  • Electronic labeling accessibility for software-only devices
  • Prescription device labeling requirements (Rx only designation)
  • Integration with FDA Establishment Registration and Device Listing

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Guide

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Regulatory Marking Requirements

Your device label must display the CE marking prominently to indicate conformity with EU MDR requirements. The CE marking must be visible, legible, and indelible, which for software means it should be permanently accessible within the user interface. Include the medical device symbol to clearly identify your software as a medical device, helping users understand the regulatory status and intended medical purpose.

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Device Identification Information

Clearly display your device name exactly as specified in your technical documentation and regulatory submissions. Include the complete manufacturer name and address as registered with regulatory authorities. This information enables proper identification and contact for regulatory, safety, or support purposes. Ensure consistency between your label information and all other regulatory documentation.

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UDI System Compliance

Display both the UDI-DI (Device Identifier) and UDI-PI (Production Identifier) with appropriate symbols. The UDI-DI identifies your device model while the UDI-PI identifies the specific software version and release date. Format the UDI-PI according to established standards with proper identifiers for software version and release date. This enables complete traceability throughout the device lifecycle.

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Version and Release Information

Include the software version number and release date prominently on your device label. Use the version numbering scheme established in your Software Development and Maintenance Plan to ensure consistency across all documentation. The release date should match the date when the software version was made available to users, providing clear temporal identification for regulatory and support purposes.

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Instructions for Use Reference

Provide clear information about where users can access the Instructions for Use (IFU). For software devices, this typically includes a web URL or electronic location where the complete IFU can be accessed. Use the appropriate symbol to indicate electronic instructions for use, helping users understand how to access complete usage information.

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Authorized Representative Information

If you are a non-EU manufacturer, include authorized representative information as required by MDR Article 11. Display the authorized representative symbol along with contact information for your EU-based representative. This enables EU authorities and users to contact a local representative for regulatory and safety matters.

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Safety Information Integration

Include appropriate warnings and precautions references on your device label. While the complete safety information is typically in your Instructions for Use, the label should direct users to review all warnings and precautions before use. This ensures users are aware of important safety considerations and know where to find complete safety information.

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Electronic Accessibility Requirements

For software medical devices, ensure your device label is easily accessible within the software interface. Consider placing it in an “About” section, settings menu, or help section where users can readily find it. The label should be accessible without requiring special permissions or administrative access, ensuring all users can view the regulatory information when needed.

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Example

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Scenario

You are creating a device label for your AI-powered diagnostic imaging software version 4.1.2 that analyzes chest X-rays and provides diagnostic recommendations to radiologists. The software is classified as Class IIa under EU MDR and is manufactured by MedTech Innovations Inc. based in California, with an authorized representative in Germany.

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Example Device Label

This product is a Class IIa medical device according to EU MDR 2017/745.

ChestScan AI Pro

(01)04012345678901(11)240315(10)4.1.2

MedTech Innovations Inc. 1234 Innovation Drive, Suite 100 San Francisco, CA 94105, USA

Software released on March 15, 2024

Software version 4.1.2

Instructions available for use at https://www.medtechinnovations.com/chestscan-ifu

European Authorized Representative: MedDevice Regulatory Services GmbH Regulatory Affairs Department Hauptstraße 123, 10115 Berlin, Germany Tel: +49 30 12345678 Email: regulatory@meddevice-services.de

Warnings and Precautions:

Please refer to the instructions for use for a full listing of warnings and precautions.

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Q&A