EN ISO 14971 is an international standard titled "Medical devices - Applying risk management to medical devices". It provides a framework for manufacturers to identify, analyse, evaluate and control the risks associated with medical devices throughout their lifecycle. Another important part of risk management under this standard is Benefit-Risk Analysis. Benefit-Risk Analysis of Medical Devices is difficult and interesting and is explicitly required in Annex I of the MDR. While producing medical devices, the benefits to the patient are taken into consideration. But in addition to this situation, the class of the medical device, the place of use, the way it is used, the working principle of the device, etc. There are always risks to arise and an effective risk management process is established to keep these risks under control. Comparison of these two situations is essential for medical device. When performing a benefit-risk analysis, it must be demonstrated that the benefits of the device outweigh the risks and must be proven with the necessary documentation.

Benefit-Risk Analysis is a systematic process that helps assess the balance between the benefits of a medical device and the risks associated with it. The following steps play a key role in an effective Benefit-Risk analysis process;

Define scope: Clearly define the purpose and content of the analysis, including the medical device in question, its intended use, and target audience.
Identify and describe benefits: Identify all potential benefits that the medical device can provide to patients or users. This process; health outcomes, quality of life, diagnostic accuracy, treatment efficacy, etc. may include improvements.
Identify and identify risks: Identify all potential risks associated with the use of the medical device. This includes damage, injury or adverse events resulting from normal use or reasonably foreseeable misuse.
Evaluate the benefits: Evaluate the magnitude of each identified benefit, taking into account the available clinical evidence, expert opinion, and user feedback. Assign a significance level to each benefit based on its impact on patient care and health outcomes.
Evaluate risks: Evaluate the severity and probability of occurrence of each identified risk. Consider factors such as the nature of risk, population at risk, duration of exposure, and likelihood of harm. Assign a severity level to each risk based on its potential impact on patient safety.
Analyze the benefit-risk balance: Compare the benefits and risks identified in steps 4 and 5 to determine the overall benefit-risk balance. Consider the relative importance of each benefit and risk and weigh them against each other. This analysis helps make informed decisions about the acceptability of risks associated with benefits.
Document the analysis: Document the entire Benefit-Risk Analysis process, including identified benefits, risks, evaluation criteria, results, and any decisions made. This documentation serves as evidence of compliance with risk management requirements and facilitates communication with regulatory authorities.

It is important to note that Benefit-Risk Analysis should be an ongoing process throughout the lifecycle of a medical device as new information and data become available. It helps manufacturers to continuously evaluate and update the benefit-risk balance, ensuring the safety and effectiveness of the device in its intended use.

Therefore Benefit-Risk Analysis is done at the following stages of CE Marking!

1. As part of risk management throughout the lifecycle of the Medical Device, all risks should be mitigated as much as possible without affecting the benefit-risk ratio.
2. Clinical evaluation should include clinical evidence for benefit-risk analysis.
3. Data collected during Post-Market Inspection should be reviewed to update the benefit-risk assessment and its continuous reassessment.
4. Non-serious events or adverse events should be analyzed in terms of risk-benefit and those with significant impact should be reported as a trend.

With its expert staff and effective experience, Infigen Consultancy can help plan, create, update or correct the risk management process. Critically, we can also ensure that your Risk Management Process is tied to your other regulatory processes, in line with the expectations of MDR, EN ISO 14971 and newly issued ISO/TR 24971.