Citation de Denis PARZY le 2 août 2023, 10 h 13 min

Hello,

It is a about a risk analysis for an electromedical device (class 2a) with a software.

Let’s consider a risk with a low probability and a high severity. The risk before implementation of control measures is acceptable. This risk does not result from a hazard of software origin.

EU MDR states that you must “reduce risks as far as possible” meaning you need to consider risk reductions for all risks, regardless of the risk level.

So, a control measure is implemented. It is a software one.

The MANUFACTURER shall assign to each SOFTWARE SYSTEM that contributes to the implementation of a RISK CONTROL measure a software safety class based on the possible effects of the HAZARD that the RISK CONTROL measure is controlling.

If the possible effect of the HAZARD is a non-serious injury, shall the SOFTWARE SYSTEM that contributes to the implementation of a RISK CONTROL measure be classified as B even if the initial risk was acceptable? In this case, would'nt we have better not to implement any risk control measure (we would prefer to have a class A software).

Thank you in advance for your help.

Christine