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Benefit is termed as positive impact or desirable outcome of the use of a medical device on the health of an individual, or a positive impact on patient management or public health. Benefits can include positive impact on clinical outcome, the patient’s quality of life, outcomes related to diagnosis, positive impact from diagnostic devices on clinical outcomes, or positive impact on public health.
EU MDR and EU IVDR Annex, I GSPR no. 1 states that the device shall be designed and manufactured such that the risk connected to the use of device should be acceptable when weighed against the benefits to the patients.
EU MDR and EU IVDR Annex, I GSPR no. 2 requires to reduce risk as far as possible without adversely affecting the benefit-risk ratio. It implies that each individual risk shall be outweighed by the benefits and if the risk is not outweighed by the benefit then the risk should be eliminated or reduced as far as possible, even if this means foregoing the associated benefits, as to do so will improve the benefit-risk ratio.
Persons involved in determining benefit-risk analysis shall consider technical, regulatory, economic and sociological context of their risk management decisions. Applicable regulatory requirements or standards shall also be considered.