Well, I agree that the standard was deliberately created with some very specific requirements for some of the records (and this was discussed a lot during JWG meetings), but even as it is, it?s not take black and white, and this is part of the problem - standards such as ISO 1481, IEC 62304, IEC 62366 were really not created to be assessed such as a type testing standard with very detailed testing and records requirements. But now, as people assess them, those details usually creates a lot of problems.
Anyway,
There?s in fact more than one requirement.
Then
The first one does require that the manufacturer use the priority listed. So, if he simply uses a warning, it seems fair to me, if analyzing compliance with the standard, to ask why the last one was out of order. Which would end up in in a justification of why a warning was used, in the end.
Regarding 6.3, the activities themselves should be detailed or referenced in the risk management plan, as explained in F.6 (quoted below).The requirements in 6.3 are really only related to the results, as you mentioned, because of that.
Anyway,
There is no requirement to justify, for example, why a warning was used.
The manufacturer shall use one or more of the following risk control options in the priority order listed:
a) inherent safety by design;
b) protective measures in the medical device itself or in the manufacturing process;
c) information for safety.
a) inherent safety by design;
b) protective measures in the medical device itself or in the manufacturing process;
c) information for safety.
The risk control measures selected shall be recorded in the risk management file.
Regarding 6.3, the activities themselves should be detailed or referenced in the risk management plan, as explained in F.6 (quoted below).The requirements in 6.3 are really only related to the results, as you mentioned, because of that.
F.6 Verification activities
The risk management plan will specify how the two distinct verification activities required by this International Standard will be carried out (see also A.2.6.3). Verifying the effectiveness of risk control measures can require the collection of clinical data, usability studies, etc. (see also 2.28) The risk management plan can detail the verification activities explicitly or by reference to the plan for other verification activities.
The risk management plan will specify how the two distinct verification activities required by this International Standard will be carried out (see also A.2.6.3). Verifying the effectiveness of risk control measures can require the collection of clinical data, usability studies, etc. (see also 2.28) The risk management plan can detail the verification activities explicitly or by reference to the plan for other verification activities.