How does the Professional Use Only designation relate to risk classification?
Answer
It is typically layered on top of the base risk classification.
This designation is not a separate risk class itself but an additional regulatory restriction. It is applied alongside the base classification (Class I, II, or III) to denote that, regardless of the risk level, the intended use necessitates professional oversight. This ensures that safety requirements are met through human intervention and training rather than relying solely on the device's intrinsic risk category.
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