The Benefit-Risk analysis (a.k.a. Benefit-Risk determination or Benefit-Risk ratio) is one of the most misinterpreted areas of the Risk Management process, in particular when coupled with the requirements of MDR / IVDR.
And consequently one of the preferred digging points for the Notified Bodies.
The spirit of the regulations and standards is “the benefit provided by the use of the device must outweigh the associated risk”.
That sounds simple doesn’t it?
Let’s take a step back.
The basic requirements are listed in ISO 14971 (EN ISO 14971:2019+A11:2021):
- Par. 7.1: “If, during risk control option analysis, the manufacturer determines that risk reduction is not practicable, the manufacturer shall conduct a benefit-risk analysis of the residual risk.”
- Par. 7.4: “If a residual risk is not judged acceptable using the criteria established in the risk management plan and further risk control is not practicable, the manufacturer may gather and review data and literature to
determine if the benefits of the intended use outweigh this residual risk.”
What often slips through the cracks is that the ISO 14971 is usually supplemented by additional requirements in each region. In particular, when the EU adopts a standard, additional information is added to it. Unlike the 2012 version, the latest EN version of ISO 14971 does not contain detailed additional requirements in Annexes ZA and ZB.
But what was in ZA and ZB of the previous version still applies. In particular:
- A Benefit-Risk analysis is not a way out of an unacceptable risk. Unacceptable risks are unacceptable.
- A Benefit-Risk analysis must always be carried out:
- The Benefit of using the device vs the Overall residual risk.
- Each residual risk vs the benefit of that specific feature under analysis.
To summarize: ALWAYS carry out a Benefit-Risk analysis before a product is placed on the market, and include ALL risk items, regardless of their acceptability.
How to Conduct a Benefit-Risk Analysis
Benefit-(Overall residual) Risk Analysis in 3 Simple Steps:
- Summarize all risk items from all risk analysis documents;
- e.g. using diagrams, charts, statistics, etc.
- Summarize the traceability to risk mitigation actions;
- Arrange a review with the project team, management, Regulatory, Quality and ideally an external expert on the device / use (e.g. a doctor / specialist / surgeon):
- Agree that the risks have been mitigated As Far As Possible and additional risk controls do not significantly reduce the risk.
- Agree that each residual risk is acceptable.
- Agree that the overall residual risk is acceptable.
- Agree that the benefit of using the device outweigh the residual risk
- Summarize the outcome of the Review into the Risk Management Report.
- The Benefit-Risk assessment is only a part of the Risk Management Review / Report, don’t forget it!
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