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A numerical benefit–risk score cannot by itself explain where evidence is strong or uncertain. Connect the device claim, conditions of use and available data explicitly. Uncertainty should remain a visible part of the decision.
Define the assessment
Link each important benefit and risk to supporting data, represented groups and follow-up duration. Observing no event differs from establishing absence of risk. Clinical importance, frequency, severity and confidence in evidence are different dimensions; preserve those distinctions within summary tables.
Worked example
For example, a short investigation shows functional improvement but limited long-term durability information. The team does not extend the favourable result across the device’s entire lifetime. It separately records benefit evidence and durability uncertainty, explaining how current controls and further follow-up address that uncertainty. Unknowns are not hidden with a zero score.
Practical checks
- State evidence source, scope and confidence for each important conclusion.
- Record unrepresented use conditions or follow-up periods as explicit uncertainties.
- Link remaining questions to risk controls, further evidence or monitoring decisions.
Decision and limitations
The decision should explain the conditions and limits under which it was made. Avoid unsupported arithmetic suggesting that unlike harms and benefits simply cancel out. Qualified clinical and risk reviewers should also define triggers for reassessment when evidence changes; this exercise is not a universal approval formula.
Frequently asked questions
- Does no observed event mean no risk?
- No. Sample size, follow-up and event-capture methods limit that conclusion.
- Does uncertainty prevent every decision?
- Not necessarily. Explain its nature, consequences and management through reasoned assessment.