Since ISO 14971:2012 is not a standard, it is not clear how to answer the question. The answer differs between ISO 14971:2007 and EN ISO 14971:2012 Annex ZA.
For ISO 14971:2007, as described in Clause 6.5, the manufacturer my encounter a situation where an individual residual risk is unacceptable and further risk control measures are not practicable. Then the manufacturer may try to determine if the benefit outweighs the individual residual risk. If the medical benefits outweigh the individual residual risk, then the manufacturer may proceed.
In this case, a risk/benefit analysis is rare, because the manufacturer seldom encounters the triggering situation (unacceptable residual risk and no additional risk reduction measures).
The situation changes with EN ISO 14971:2012 Annex ZA. The content deviations inform the manufacturer when the MDD differs from ISO 14971:2007. In this instance, Content Deviation 4 applies. The content deviation concludes that the manufacturer must undertake the risk-benefit analysis for the individual risk … in all cases.
In this case, each individual residual risk must have a risk/benefit analysis; one is required "in all cases". There is no requirement that each one be unique. Similar individual residual risks, arising from different hazards, hazardous situations, and harms, may have the same risk/benefit analysis.
There are two important issues. The first is whether the conclusion in Content Deviation #4 logically follows from Annex I, Section 6. Since that deals with "undesirable side-effects", I have a hard time reaching the conclusion.
The other issue is the Consensus Paper which suggests "a risk‐ benefit analysis for individual [residual] risks that are not acceptable according to the criteria explained in Content Deviation #2 and for which further risk reduction is not possible". This implies acceptable risks don't require a risk/benefit analysis, but it doesn't state that position.
In addition, it brings in Content Deviation #2, which starts by saying that ISO 14971:2007 says that only non-acceptable risks have to be integrated into the overall risk-benefit analysis. I expected the conclusion to affirm that risk/benefit analysis applies to both acceptable and unacceptable risks, but the conclusion is not a straight line from the premises.
Because Content Deviation #4 says, in all cases, I would consider failure to cover all cases (both acceptable and unacceptable residual risk) as a non-conformance to MDD Annex I, Section 6 as described in Content Deviation #4.
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Dan O'Leary
Swanzey NH
United States
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Original Message:
Sent: 17-Aug-2017 06:32
From: Silambarasan Subramanian
Subject: Risk Vs Benefit - ISO 14971:2012
Hi Team,
I have prepared the Risk Management file recently along with cross functional team, to comply with ISO 14971:2012 requirements.
I am not very clear with the requirement for risk vs benefit. Is risk vs benefit statement required for every single hazard or overall risk vs benefit statement is enough?
Please provide your suggestions.
Thanks in advance.
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Silambarasan Subramanian
Senior Engineer - Quality & Regulatory Affairs
Schiller Healthcare
India
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