Benefit-risk determination

A benefit-risk determination is the documented judgment that the clinical benefits of a device outweigh the residual risks, for the intended patients and use.

ISO 14971 asks the manufacturer to evaluate residual risk against the benefits of the intended use. The EU MDR repeats that idea in the General Safety and Performance Requirements and in the clinical evaluation and post-market duties. The judgment is not a slogan. It cites the residual risks you could not design out, the benefit you claim, and the data that support both. It is updated when post-market information changes either side.

Risk management and clinical evaluation are easy to store in two PDFs that never meet. A complaint trend that changes residual risk should change the risk file and, if needed, the labeling or the device. That change is often a CAPA.

HAVGATE does not replace an ISO 14971 risk-management file. Audit tasks in MDSAP Chapter 1 include risk-management planning, and CAPA records are where you show the response when new information arrives.