Technical documentation section 5. Risk management:

5.3 Risk management report

The risk management report is the final output of the risk management process conducted in accordance with ISO 14971 and the requirements of the MDR. It documents the overall assessment of residual risk, evaluates the effectiveness of risk control measures, and provides conclusions on the acceptability of risks associated with the medical device.

Purpose of the report

The purpose of the risk management report is to present a comprehensive overview of the risk management activities carried out under the scope defined in the risk management plan. It serves as evidence that the manufacturer has applied a structured and systematic process for risk identification, evaluation, control, and review throughout the product life cycle.

Content of the report

The report includes the following elements:

• Summary of risk management activities conducted as per the risk management plan
• Confirmation that the risk management file is complete and up to date
• Overview of identified hazards, hazardous situations, and associated harms
• Summary of risk evaluation outcomes and criteria used
• Description of implemented risk control measures and verification of their effectiveness
• Assessment of overall residual risk and justification of acceptability
• Conclusions on whether the benefits of the device outweigh the residual risks

Timing and authorship

The risk management report is issued upon completion of the risk analysis and implementation of control measures. It is typically finalized before initial device release or submission to a Notified Body. The report is prepared by the person responsible for risk management activities and approved by management as per the responsibilities defined in the risk management plan.

Relation to other documents

The report forms part of the risk management file and is linked to the design and development documentation, clinical evaluation report, and post-market surveillance planning. Updates to the risk management report may be required in response to changes in device design, feedback from post-market surveillance, or field safety corrective actions.