Technical documentation section:
5. Risk management
The risk management section of MDR-compliant technical documentation provides a comprehensive and structured demonstration of conformity with the risk-related requirements of the regulation. It describes the manufacturer’s application of a risk management process throughout the lifecycle of the medical device.
Risk management plan
The risk management plan defines the scope, responsibilities, criteria for risk acceptability, and methods used for risk analysis, evaluation, control, and monitoring. It identifies the medical device under assessment and ensures traceability between hazards, risks, and control measures.
Risk analysis and control documentation
This part includes detailed risk analysis for the medical device, identifying known and foreseeable hazards associated with intended use and reasonably foreseeable misuse. It documents the estimation of the associated risks, the implementation of risk control measures, and the assessment of residual risks.
- Hazard identification and classification
- Risk estimation for identified hazards
- Risk control measures and implementation status
- Assessment of residual risks and benefit-risk analysis
- Traceability between risks and mitigations
Risk management report
The risk management report provides a final review and summary of the overall risk management process. It confirms that the medical device has met the risk acceptability criteria and that residual risks are outweighed by the clinical benefits. The report also includes conclusions about the completeness of risk management activities and any planned post-market risk monitoring.
Below, you will find links to information about the documents included in Section 5 of MDR-compliant technical documentation, covering key requirements for risk management documentation.
