Introduction
The Benefit-Risk analysis is one of the most misinterpreted areas of the Risk Management process.
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 (2019) par 6. This paragraph allows for the following case:
“If the risk is acceptable, it is not required to apply the requirements given in 7.1 to 7.5 to this hazardous situation (i.e., proceed to 7.6) and the estimated risk shall be treated as residual risk.” which means no Risk Control and no Benefit-Risk analysis.
What often slips through the cracks is that the ISO 14971 is usually supplemented by additional requirements in each region.
In the EU the latest MDR and IVDR have more stringent requirements (e.g. MDR Annex I Chapter I Section 8 GSPR):
“All known and foreseeable risks, and any undesirable side-effects, shall be minimised and be acceptable when weighed against the evaluated benefits to the patient and/or user arising from the achieved performance of the device during normal conditions of use.”
In the EU MDR, “benefit-risk” is mentioned 27 times, plus other instances where benefits are required to be weighed against risks.
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 Risk/Benefit Analysis?
Risk/Benefit Analysis in 3 Steps
- Summarize all risk items from all risk analysis documents and traces to risk mitigation actions; this includes residual anomalies (for software), warnings and contraindications;
- Summarize all proven benefits of the use of the device, and if available their probability.
- Arrange a review with the project team, management, Regulatory, Quality and ideally an external expert on the device / use (e.g. a surgeon):
- Agree that the risks have been mitigated As Far As Possible and additional risk controls do not significantly reduce the risk.
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Agree that each residual risk is acceptable.
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Agree that the overall residual risk is acceptable.
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Agree that the benefit of using the device outweighs the residual risk.
How to estimate benefits?
The benefit arising from a medical device is related to the likelihood and extent of improvement of
health expected from its use.
Benefit can be estimated from knowledge of several factors such as:
- the performance expected during clinical use;
- the clinical outcome expected from that performance;
- benefits resulting from the use of similar medical devices;
- factors relevant to the risks and benefits of other diagnosis or treatment options.
The following aspects should be taken into account:
- the type of expected benefits for the patient or other people (e.g. the medical device is life-saving or essential in a given medical scenario);
- the magnitude of the expected benefits (e.g. the degree to which the patient will experience the therapeutic or diagnostic benefit);
- the probability that the patient will experience the expected benefits (i.e. the likelihood that the
medical device is effective in treating or diagnosing the patient’s disease or condition); and - the duration of the expected effects (i.e. how long the benefit is expected to last for the patient).
Criteria for benefit-risk analysis
The team involved in making the benefit-risk analysis must be able to understand and take into account the technical, regulatory, economic and sociological context of their risk management decisions.
When assessing the residual risk, the safety requirements specified by standards addressing specific products or risks can be presumed to be consistent with an acceptable level of risk, especially where the use of those standards is sanctioned by the prevailing regulatory system.
Note that a clinical investigation might be required to verify that the balance between benefit and residual risk is acceptable.
The following should also be taken into account:
- characterization of the disease or condition of the intended patients;
- the uncertainty of data;
- production and post-production information for similar medical devices that are already available on the market;
- the generally acknowledged state of the art (e.g. standards);
- a comparison of the benefits of the medical device under development with the benefits of similar medical devices available on the market;
- a comparison of the residual risks of the medical device under development with the residual risks of similar medical devices available on the market.
Further guidance can be found in:
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ISO 14971:2019 par. A2.7.4
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TR 24971:2020 par 7.4 / H.4 (recommended reading)
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