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Classification of active medical devices (including software-based medical devices)

Guidance

Guidance to help manufacturers of active medical devices, including software-based medical devices, to classify their devices.

Last updated

Contents

  • About this guidance
  • The classification proces
    • Introduction
    • Applying the classification rules
  • Classification rules
    • Detecting, diagnosing, screening, monitoring, investigation
    • Therapy
    • Recording patient images and anatomical models
    • General rule for any other active medical device

Supporting documents

Topics

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