Benefit/Risk Ratio

A Clinical Evaluation Report (CER) is not complete without a proper benefit-risk determination, defined in EU MDR 2017/745 Article 2(24) as the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer. According to Article 2(53), clinical benefit means the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health.

These two articles lay the foundation for Chapter VI Article 61(1), according to which conformity needs to be confirmed with General Safety and Performance Requirements (GSPRs) that are relevant to the device when used as intended under normal conditions, to determine the acceptability of the benefit/risk ratio. In line with this, Annex I Chapter I Section 1 states that medical devices must be safe and effective, while not compromising the clinical condition of the patient or the safety and health of users. Any risks associated with the device must be weighed against the benefits to the patient, taking into account the generally acknowledged state-of-the-art (SOTA). Furthermore, Annex I Chapter I Section 8 mandates that all known and foreseeable risks, including undesirable side effects, are minimized and deemed acceptable when weighed against the evaluated benefits to the patient and user.

This critical assessment is based on ISO 14971, which instructs device manufacturers to reduce risks as far as reasonably possible, so that the claimed benefits of the medical device outweigh any risks and potential side effects, with respect to the SOTA, including competitor devices and alternative treatment options that are available to the patient.

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