In the “Benefit-Risk analysis” step, all Hazards with Residual Risk will be displayed.
Click on the “pencil” icon in the “Disclosure of residual risk” field and identify what is to be communicated and to whom this is directed to inform, motivate and enable the user to use the device safely and effectively.
In the “Resulting benefits” field type in the benefits of the risk analysis.
Alternatively, click the “Edit” walk through the questions that will help in determining the context and extent of residual risk.
The following question will be proposed based on if is this Benefit-Risk analysis related directly to risks from a Medical Device?
- Does the Residual risk affects - Cybersecurity, the patient, the operator, the environment, the equipment, the process, undesirable
- Does the Residual Risk may be a result of - Security Breach, Misuse, Fault Conditions, Failure, Normal Use
- To what type of performance is the residual Risk related to - Basic, Standardized, Susceptible, Critical
- Factors why further risk reduction or additional design controls were deemed impractical
- Why was the original risk not deemed an "acceptable risk"?
- Would further Residual risk reduction create or increase other mitigated risks?
- What would be the effect of doubling the control measures?
- How is Residual risk related to the intended use?
- What would be the effect of removing the requirement causing the Residual risk?
- Does the Residual Risk reduce the innate Benefit to the patient?
- Would Residual risk change the probability of FP or FN? (False Positive or False Negative)
- Type of benefit
- Who does the benefit target?
- The magnitude of benefit (a. The degree to which patients experience the treatment benefit or effectiveness of the Medical device; b. Change in patient's condition or change in necessary clinical management; c. Benefit as assessed against Standard of care and expected performance; d. Start of effect; e. Duration of the effect
- Will the patient be able to understand the risk?
- Will the patient be conscious when Risk is explained?
- Patients understanding of Benefit/Risk (table/chart)
- Is the anticipated or innate benefit achievable through the use of - alternative design, or other devices already in Marketplace, or therapeutic options that avoid the exposure to task risk or reduce the overall risk, or none of above
- Compared to other devices, are the Benefits and Risks - significantly more, somewhat more, similar, same, somewhat less, less
- Compared to alternate treatment outcomes, does Residual risk make - pain, mobility, morbidity, side effects, recovery times, long term effects
- Basis of evidence used for Benefit-risk analysis - clinical investigation, clinical evaluation, clinical estimation, literature review, other
In case if it's more benefit-Risk Analysis required, you need to start a task or a process, if not, competition of labeling and mitigations is required to describe.
To Approve the Risk, choose "Approve" in 3 dots menu:
Select "Approve", and confirm with button "Approve selected".
Approve with your PIN code.
Now, when the Risk Analysis is finished, you can do Re-evaluation or go back to Dashboard:
