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Examples of regulated and unregulated software (excluded) software based medical devices

11 October 2021
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Description

This document presents examples that illustrate the boundaries between regulated and unregulated software.

  • About this guidance
    • Regulatory changes for software
  • Walkthrough examples
    • Is the software intended to be used for a medical purpose?
    • Does the software meet the exclusion criteria?
    • Example 1: Kilojoule counter
    • Example 2: Software for tracking health information
    • Example 3: Software that is used to diagnose hypertension and risk of cardiac disease
    • Example 4: Software that controls an insulin pump
  • Examples of excluded software
  • Examples of regulated software
    • Class I
      • Neural network for monitoring shingles
      • Other Class I examples
    • Class IIa
      • Diabetes diagnosis software
      • Other Class IIa examples
    • Class IIb
      • Cardiac MRI analyser
      • Diagnosis of acute arterial occlusion
      • Recommendation of a treatment or intervention
      • Other Class IIb examples
    • Class III
      • Specifies a treatment or intervention
      • Other Class III examples
  • Excluded software versus regulated software
    • Clinical decision support software

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