
It is intended to have no risk remaining in the red region.
All remaining risk shall possibly be in the green region.
Risk remaining in the yellow region has to have a clear medical rational.
Risks which do not appear in the acceptable region after implementation of all risk control measures will always be communicated to and approved by the management.
Any Risk remaining in the S-5 region will be specifically observed by post-market surveillance and the first occurring event is going to trigger an escalation plan.
All risks, regardless of their dimension, need to be reduced as much as possible & need to be balanced, together with all other risks, against the benefit of the device.
Not apply any criteria of risk acceptability prior to all risks reduced as far as possible. All risks combined, regardless of any "acceptability" assessment; need to be balanced, together with all other risks, against the benefit of the device.
Risks to be reduced "as far as possible" without there being room for economic considerations.
Manufacturer must undertake the risk-benefit analysis for the individual risk and the overall risk-benefit analysis (weighing all risks combined against the benefit) in all cases.
To acknowledge state of the art; Always must apply all the "control options" and may not stop his endeavors if the first or the second control option has reduced the risk to an "acceptable level" (unless the additional control option(s) does not improve the safety).
Users shall be informed about the residual risks.