Hi,
The intended use is what we say (labelling, statements in the clinical evaluation) our device is intended to be used for.
There is potentially a difference between the intended use and what the device is actually used for by customers. An illustrative example: A (car) manufacturer could state that they sell benches/devices to sit on. There happens to be a (steering) wheel in front of one bench, and an engine below it, and customers use the device to sit and to drive from A to B. Potentially, the (car) manufacturer even tested the driving feature, however still markets their device as "bench".
I have a few questions regarding this:
Q1: Is the extent of this difference somehow regulated/limited?
Q2: What are the implications of such a difference?
Q3: How does this affect the scope of the risk management?
Regarding Q3 with reference to the car example: Strictly considering the intended use (a device to sit on), probably the worst risk would be a buttock lump due to a collapse of the bench. Once we know that there is also an engine below one bench, we would consider the risk of death/severe injury due to extensive heat or explosion of the engine. However, we would not consider risks associated with driving/speed/traffic. Nevertheless, not documenting risks associated with driving/speed/traffic seems a bit odd because when assessing risks probably those risks would come up.
Thanks
The intended use is what we say (labelling, statements in the clinical evaluation) our device is intended to be used for.
There is potentially a difference between the intended use and what the device is actually used for by customers. An illustrative example: A (car) manufacturer could state that they sell benches/devices to sit on. There happens to be a (steering) wheel in front of one bench, and an engine below it, and customers use the device to sit and to drive from A to B. Potentially, the (car) manufacturer even tested the driving feature, however still markets their device as "bench".
I have a few questions regarding this:
Q1: Is the extent of this difference somehow regulated/limited?
Q2: What are the implications of such a difference?
Q3: How does this affect the scope of the risk management?
Regarding Q3 with reference to the car example: Strictly considering the intended use (a device to sit on), probably the worst risk would be a buttock lump due to a collapse of the bench. Once we know that there is also an engine below one bench, we would consider the risk of death/severe injury due to extensive heat or explosion of the engine. However, we would not consider risks associated with driving/speed/traffic. Nevertheless, not documenting risks associated with driving/speed/traffic seems a bit odd because when assessing risks probably those risks would come up.
Thanks