Page 233 - Safety Risk Management for Medical Devices

212 Safety Risk Management for Medical Devices

2. Identify those functions whose failure or degradation could lead into a Harm.
These are candidates for Essential Performance.
3. Use the Risk Assessment and Control Table to determine the risk levels for
each candidate function from Step (2). If the residual risk for a clinical function
is unacceptable, then that clinical function is part of the Essential Performance
of the device.

Note that it is possible to have a medical device with no Essential Performance.
What that means is that the device risks are controlled in such a way that the loss or
degradation of any of its clinical functions do not result in unacceptable risk.