It is not required to includeseverity and occurrence associated with each disclosed harm.Disclose residual risks related to risks whose mitigation option was to provide information to the user.Disclose expected and foreseeable {MQ}product related{MQ} adverse events that may be identified in future complaints that are typically reportable to a regulatory authority {MQ}based on product performance/trend reports{MQ}.Disclosed residual risks (for example, disclosed in IFU) must be included in the risks assessed within the Risk Management File (RMF).