Medical device manufacturers cannot depend on procedures to decrease the risk as they used to do in the past. Additionally labeling must be still shown on the medical devices, but it cannot be longer used to mitigate risk. The idea of decreasing risk as low as reasonably practicable (ALARP), which contains economic concerns, was swapped with an obligation to decrease risk as far as possible (AFAP). This way the complexity of the reduction and risk assessment is more complex than it was in the past. Additionally, the evaluation of the risks in the phase design and in the clinical stage is much different.

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