Benefit-risk determination

Under the EU MDR and IVDR this is a conclusion that runs through the risk management file, the clinical or performance evaluation and the post-market reports. Notified bodies expect the same conclusion and the same data to appear consistently in all of them.

‘benefit-risk determination’ means 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;

EU MDR, Article 2(24)

‘benefit-risk determination’ means 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;

IVDR, Article 2(17)