Benefit Risk Analysis: When the overall residual risk remains unacceptable and further risk control is not practicable, then there would be a need for risk-benefit analysis. In a risk-benefit analysis, a manufacturer shall review data and literature to determine if the medical benefits of the intended use outweigh the overall residual risk and hence a ratio. The manufacturer must undertake the risk-benefit analysis for the individual risk and the overall risk-benefit analysis (weighing all risks combined against the benefit) in all cases
Once the product is launched to the market, Post Market data should be considered for the analysis. When the product is used in reality, a better assessment can be made of the risks and benefits it poses. With the data that is collected from the market will help to improve the benefits and allow for fewer risks in the product.
The medical devices undergoing the risk management activities when further risk reduction not possible, risk-benefit analysis should be performed.
The benefit risk analysis comparison should be done based on the following factors, as per the worksheet,
- Number of significant Risks & Benefits
- Duration of effects
- Patient, Caregivers, Healthcare professional perspective