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Benefit Risk Analysis 191

upper left quadrant of Fig. 23.1. If on the other hand, the new device delivers less bene-
fit for the same or more risk, then clearly the benefit does not outweigh the risk. This
is represented by the lower right quadrant of Fig. 23.1. These are the clear cases. The
upper-right and lower-left quadrants are not so clear and require a deeper analysis.
The degree to which different patients benefit from a medical device varies. BRA
should be done on the overall target population. It may be that the benefit to risk
ratio is acceptable for part of a target population and not for the entire population.
For example, imagine a medical device that provides more benefit at a lower risk for a
younger population than an older population. It may be determined that only patients
under a cutoff age should be indicated for the use of the medical device.

23.1 BENEFIT RISK ANALYSIS IN CLINICAL EVALUATIONS

Clinical evaluations or studies are a special case in the risk management of medical
devices. In a clinical evaluation, the subject medical device may not be approved for
commercial release. It may not have any benefits that the manufacture could claim.
And, the clinical study may present safety risks to the study participants. Still the ben-
efit/risk profile is expected to be evaluated and shown to be acceptable for the
intended study target group.
For clinical studies, according to MEDDEV 2.7/1 [32], it is expected that the risks
associated with the performance of the clinical study are minimized and
acceptable when weighed against the benefits to the patient and are compatible with a
high level of protection of health and safety.
With respect to the acceptability of benefit risk ratio in clinical evaluations MEDDEV
2.7/1 [32] advises to evaluate the clinical data on benefits and risks of the device under
evaluation when compared with the current SOTA in the corresponding medical field.
Per MEDDEV 2.7/1 [32] for clinical investigations, typically the following items
are considered:

• clinical background
2 information on the clinical condition to be treated, managed, or
diagnosed
2 prevalence of the condition
2 natural course of the condition
• other devices, medical alternatives available to the target population, including
evidence of clinical performance and safety
2 historical treatments
2 medical options available to the target population (including conservative,
surgical, and medicinal)
2 existing devices, benchmark devices