I am struggling to understand how to estimate overall residual risk (as it is also described in ISO 14971:2019). In fact, I am trying to make it simple in order to understand it. I would very much appreciate if you can provide some help by considering an example:

I have (for example) a medical device or an in vitro diagnostic medical device. Lets assume that for this device I have identified 3 hazards/hazardous situations and after analysing the associated risks (by using for example a 3x3 risk matrix--> probability of occurence of the harm and severity of the harm), I get the following risk levels (by adding the probability and severity values):

Hazard #1 : Risk level=2 (for example this is considered low risk)

Hazard #2: Risk level=4 (for example this is considered medium risk)

Hazard #3: Risk level=6 (for example this is considered high risk)

(Individual) Risk acceptance criterion: Risk level =<3.

For the sake of simplicity, lets assume that the above risk levels are also the final residual risk levels per hazard.

How can I estimate the

**overall residual risk**for this device?