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Examples of regulated and unregulated software (excluded) software based medical devices
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
- Class I
- Excluded software versus regulated software
- Clinical decision support software
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