Understanding SaMD Classification: A Clear Breakdown of Regulatory Categories

 

Here’s a clear breakdown of Software as a Medical Device (SaMD) classification, based on major regulatory frameworks like the International Medical Device Regulators Forum (IMDRF), FDA, and EU MDR:

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🌐 What is SaMD?

Software as a Medical Device (SaMD) is software intended to be used for medical purposes without being part of a hardware medical device.

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🧭 IMDRF SaMD Risk Categories

IMDRF sets a widely accepted framework using two dimensions:

• State of the healthcare situation or condition (Critical, Serious, Non-serious)

• Significance of the information provided by the software (Treat/Diagnose, Drive Clinical Management, Inform Clinical Management)

Condition → Info ↓	Critical	Serious	Non-Serious
Treat or Diagnose	Class IV (High)	Class III	Class II
Drive Clinical Management	Class III	Class II	Class I
Inform Clinical Management	Class II	Class I	Class I

• Class I: Lowest risk – e.g., wellness apps

• Class IV: Highest risk – e.g., software used for cancer diagnosis

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🇺🇸 FDA SaMD Classification

The FDA uses a three-class system:

• Class I (Low Risk): Minimal harm if misused.
  Example: Reminders for medication adherence.

• Class II (Moderate Risk): Needs special controls.
  Example: Software interpreting ECGs.

• Class III (High Risk): Supports life-critical decisions.
  Example: AI software that identifies strokes from imaging.

FDA often aligns with IMDRF’s framework but has its own 510(k), De Novo, and PMA regulatory pathways.

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🇪🇺 EU MDR Classification

Under the EU MDR, SaMD is categorized based on intended use and risk:

• Class I: Non-invasive, general use

• Class IIa: Monitors or supports diagnosis

• Class IIb: Software influencing treatment decisions

• Class III: Software that may cause death or irreversible harm if it fails

🔍 EU MDR uses Rule 11 specifically for software.

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FIG 1.1 SaMD Classification

🧪 Examples by Classification

Example	Likely Class
Step counter fitness app	Class I (FDA/IMDRF/EU)
Software calculating insulin dosage	Class III (FDA), Class C/D (IMDRF)
AI for tumor detection in radiology	Class III (FDA/EU), Class IV (IMDRF)
Mobile app reminding patients to take meds	Class I

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