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EU MDR Rule 11 - Does the 'Risk logic' used in Rule 11 conflict with that used in the other rules?

kreid

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#1
Hello,

Does the 'Risk logic' used in Rule 11 conflict with that used in the other rules?

It appears to me that the logic used in Rule 11 is different to that used in the older 'MDD' rules, here is an example of what I mean:

If I have a device that is active and intended to emit ionizing radiation for therapeutic purposes, it could be classified as Class IIb under Rule 9;
If, associated with that device, there is a second device which controlled, monitored or directly influenced that first device, it could be classified as Class IIb also under Rule 9;
If we accept that the ion emitting device could cause death or irreversible deterioration of health (as some of these device can and do) and that second device was a software device would it still be classified as Class IIb under rule 9 or Class III under Rule 11 (using implementing rule 3.5)?

It seems to me that saying a device that emits radiation for therapeutic purposes is Class IIb when some of these devices could cause death or irreversible deterioration of health, is using a different risk logic to that used in Rule 11.

As a second part of this question, from a general risk engineering perspective, is it possible that the risk classification of something that controls or directly influences a 'primary' device could be of a higher rsik clssification than that 'primary' device, assuming the controller introduces no more risk scenarios?
 
#2
Yes, there is a 'new logic' introduced with rule 11 and there will be quite a lot of up-classifications for active devices with software involvement.
 
#3
Perhaps what they are saying is that classification is not determined by the harm that a device could cause, but by the likelihood that the controls intended to reduce the risk of the harm might fail? I'm applying FDA's mindset here (I think), in which device classification is determined, not by risk, but by the adequacy of controls (general, special). In that case, what the regulation would be saying is that the regulators have less confidence in the controls applied to a software device than to a hardware device.

Does that work?
 
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