Rule 11 Explained: Classifying SaMD in the EU

EU MDR’s Annex VIII, Rule 11 determines how software is classified:

• Class IIa: Most diagnostic and therapeutic decision-support tools
• Class IIb: Tools whose incorrect use may lead to serious harm
• Class III: Life-critical functions (e.g., software controlling pacemakers)

What Determines the Class?

• The intended use and severity of the condition it addresses
• Whether the software makes decisions or just informs them
• If a human-in-the-loop can reliably override the software

Example:

• Software interpreting chest X-rays → Class IIa or IIb
• Sepsis detection app triggering alerts → Class IIb or III

References:

• MDCG 2019-11 rev.1
• IMDRF SaMD Categories

This post is part of SaMD Europe Launch Guide.

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