Benefit-risk determination

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.

Reference: MDR Article 2(24); IVDR Article 2(17)

Risk management

The continuous iterative process, run across the whole device lifecycle, of identifying hazards, estimating and evaluating risks, controlling them and monitoring the effectiveness of those controls. It must be established, documented, implemented and maintained, and updated with production and post-market information.

Reference: MDR Article 10(2) and Annex I Section 3; IVDR Article 10(2) and Annex I Section 3

Risk

The combination of the probability of occurrence of harm and the severity of that harm.

Reference: MDR Article 2(23); IVDR Article 2(16)