a) The feedback gathered on a product, as a best practice, can be assessed by its occurence over time, whether it exceeds the initially set occurence levels in the specific risk management file. If exceeding, actions should be taken and the benefit-risk determination might be updated.
b) With the assessment of a potential impact on usability, design and manufacturing, the specific risk assessment might be updated and thus, the outcomes of risk mitigation, including the communication of risks.
c) With the update of risk assessments and gathering of feedback from the market, the clinical evaluation report (CER) might be updated as well. Specifically, if new hazards are detected with an impact on the clinical safety.
d) With every treatment, the number of patients for a safety and clinical performance evaluation increases, and thus, the summary might be updated as well
e) Depending on the feedback and the occurence rates, CAPA or field actions might be started.
f) With every upate of the risk management triggered by feedback, the risk mitigation might be updated as well potentially leading to an optimization of the usability, design or manufacturing of the product.
g) Market data of similar products or sub-assemblies might support the informed decision making and might leverage knowledge from other products for the one in question.
h) Trending of data is relevant for early detection of potentially safety or performance relevant signals.