ISO 14971 is the international standard that specifies terminology, principles, and a comprehensive process for risk management of medical devices Risk management under this standard underpins every medical-device safety argument. The standard establishes a systematic framework for identifying hazards associated with medical devices, estimating and evaluating the associated risks, controlling these risks, and monitoring the effectiveness of the controls throughout the entire device life cycle. This letter offers a technical appraisal of the transition from ISO 14971:2007 to ISO 14971:2019, arguing that the third edition changes fewer requirements than specialists fear but shifts the epistemic centre of the standard more than they assume: risk acceptability is converted from a largely internal engineering judgement into an explicit, benefit-anchored and plan-governed decision. Five threads of the revision are examined: the formalisation of benefit and benefit–risk analysis with documented evidence; the sharpened hazard space through the defined term of reasonably foreseeable misuse; the rebuilt production and post-production loop (Clauses 9 and 10); the relocation of informative guidance to ISO/TR 24971:2020; and the resolution of the European harmonisation deviations through EN ISO 14971:2019+A11:2021.