Re: New version EN ISO 14971:2012 released - July 2012
Thank you Sam for sharing.
It's good intel to know that this is what NBs agree upon, but at the same time it's very sad that this is the best they could come up with.
First:
2. Have manufacturers shown that risks have been reduced as much as possible?
3. Have manufacturers conducted a risk benefit analysis for all risks?
IMO, these 2 contradict each other. What's the point of looking at the risk-benefit balance if risk is required to be reduced "as much as possible" anyway?!... The risk-benefit analysis was supposed to be a tool in making an informed and responsible decision that although the risk
can be reduced further, it's already acceptable, so no-more-mitigation is also acceptable.
Second:
4. As publication of residual risks in the information given to the user does not reduce the risk, but publication of residual risks and warnings used as risk control measure may be beneficial, ... and have manufacturers evaluated whether those warnings are effective...
If publication of residual risks does not reduce the risk, then how may it be beneficial as a risk control measure?!... And further, if it does not reduce the risk, how can it be effective? If something can't be effective, no one can verify that it is...
Third:
Please be ready at your next Notified Body QMS or Technical File Assessment to share evidence to show that EN ISO 14971:2012 Annex Z has been considered in your compliance to the Essential Requirements for newer devices and to share your plans for evaluating and addressing the impact of EN ISO 14971:2012 Annex Z on older and legacy devices that will continue to have CE Marking applied.
This is in contradiction with the MDD spirit. Harmonized standards as a means to comply with the ERs are
voluntary. There should have been a mention of that, or at least this instruction should have been conditional, along the lines of "if you wish to benefit a harmonized standard presumption of conformity in this context."
In summary: At least 3 major problems in a document as short as that!

Ronen.