The benefit-risk report is the central conclusion of all the risk management and clinical evaluation work. GSPR No. 1 of Annex I of the MDR sets out the fundamental requirement: a medical device must be placed on the market only if the expected clinical benefits outweigh the residual risks. This demonstration must be explicit, documented and defensible.
It is the section of the technical documentation that generates the most questions during dossier reviews. And for good reason: it synthesises all of the clinical and risk management work. A vague or circular conclusion immediately reveals the weaknesses of the dossier.
The two pillars of the demonstration
The benefit-risk report rests on two sets of data that must be explicitly set against each other.
The expected clinical benefits. They are documented in the clinical evaluation report (CER): expected clinical outcomes for the patient, improvement in quality of life, impact on morbidity and mortality, available therapeutic alternatives and comparison of benefits. The benefits must be quantified as far as possible — not generic formulations, but quantitative data drawn from the literature or from clinical studies.
The residual risks. They are documented in the risk management report in accordance with ISO 14971: list of residual risks after application of all control measures, assessment of their probability and severity, conclusion on their individual and overall acceptability (overall residual risk in accordance with ISO 14971:2019).
How to structure the conclusion
The conclusion of the benefit-risk report must explicitly answer three questions.
Question 1: are the clinical benefits demonstrated? Rely on the conclusions of the CER. Do the available clinical data demonstrate that the device delivers the claimed benefits in its target population?
Question 2: are the residual risks acceptable according to the criteria of the risk management policy? Rely on the conclusions of the ISO 14971 report. Is each residual risk within the acceptable zone of the risk matrix? Is the overall residual risk acceptable?
Question 3: do the benefits outweigh the residual risks? This is the final conclusion. It is not automatic even if the two previous answers are positive: some devices may have residual risks that are acceptable in isolation but whose combination, set against modest benefits, changes the conclusion.
What makes a conclusion unconvincing
Stating that the benefits outweigh the risks without data to support this assertion is not a benefit-risk report. Stating that the clinical benefits comply with the requirements of the standard is a tautology with no informative content.
The conclusion must cite the specific clinical data that demonstrate the benefits, the specific residual risks set against them, and the line of reasoning that leads to the conclusion that the balance is favourable. If this reasoning does not hold over two substantial pages, it is probably insufficient.