In many MDR technical files, the clinical evaluation and the risk management are two documents written separately, by different people, that do not reference one another. For notified bodies, this is an immediate signal of a compartmentalised file that does not reflect an integrated approach.
These two processes are distinct in their method and their objective. But they must feed each other so that the conclusion on the benefit/risk ratio is consistent and defensible.
How risk management feeds clinical evaluation
Risk management under ISO 14971 identifies the hazards associated with the device, estimates and evaluates the corresponding risks, implements control measures, and concludes on the acceptable residual risks.
These residual risks must be clinically validated. The question the clinical evaluation must address is: under real conditions of use, do the available clinical data confirm that these residual risks remain acceptable in light of the observed clinical benefits?
If risk management concludes that the risk of infection associated with the device is an acceptable residual risk with an expected rate of X%, the clinical evaluation must verify that the available clinical data are consistent with this estimate — that no studies or post-market data document a significantly higher infection rate.
How clinical evaluation feeds risk management
The clinical evaluation may identify risks that the initial risk analysis had not anticipated: complications documented in the literature on comparable devices, adverse effects reported in post-market clinical studies, vigilance data from other manufacturers.
These risks must be integrated into the risk management file in accordance with the ISO 14971 procedure. If a hazard was not identified during the initial analysis but appears in the literature, the manufacturer must evaluate it, implement control measures if necessary, and document this revision.
The shared conclusion: the overall benefit/risk ratio
The conclusion of the two processes converges towards the overall benefit/risk ratio. GSPR No. 1 of Annex I of the MDR requires that the expected clinical benefits outweigh the residual risks. This demonstration relies simultaneously on the clinical data (clinical evaluation) and on the analysis of residual risks after control (risk management).
In the technical file, this consistency must be visible: the conclusions of the risk management and the clinical evaluation must reference each other and lead to a shared conclusion on the overall benefit/risk ratio. A notified body that reads the two documents separately and finds no link between them will flag a consistency gap in the file.