Benefit - Risk Analysis

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.

Benefits can be described as:

• positive impact on clinical outcome
• patient’s quality of life
• outcomes related to diagnosis
• positive impact from diagnostic devices on clinical outcomes
• a positive impact on public health

Benefits can be estimated from knowledge of several factors such as: –

• expected performance during clinical use
• expected clinical outcomes from that performance
• benefits resulting from use of similar medical devices
• actors relevant to risks and benefits of other diagnosis or treatment options

Benefit-risk analysis is performed at various stages:

• As a part of risk management
• As a part of clinical evaluation, to gather clinical data for supporting benefit-risk analysis
• Data gathered as a part of Post market surveillance to update the benefit-risk
• PSUR is updated to set out the conclusions of benefit- risk determination

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.