Risk Management Support for EU MDR and IVDR
Practical RA provides regulatory support for risk management activities aligned with ISO 14971 and integrated with EU MDR and IVDR requirements.
Why Risk Mangement Matters
Risk management is a foundational requirement under the EU MDR and IVDR and underpins nearly every aspect of regulatory compliance. ISO 14971 provides the framework for identifying hazards, estimating and evaluating risks, implementing risk control measures, and assessing residual risk. Under the MDR and IVDR, this process must be demonstrably integrated with clinical evidence, post-market surveillance, and technical documentation.
Regulators now expect manufacturers to move beyond purely qualitative risk assessments. Risk management files must clearly show how identified hazards relate to device design, intended use, clinical performance, and labelling. Risk control measures must be justified, implemented, and verified, with clear evidence that residual risks are acceptable when weighed against clinical benefits.
A frequent issue encountered during regulatory review is inconsistency between the risk management file and other documentation. For example, risks identified in the risk analysis may not be adequately addressed in clinical evaluation, or labelling may not reflect known residual risks. Under the MDR and IVDR, such inconsistencies are no longer tolerated and often result in non-conformities.
Risk management is also a living process. Post-market information, including complaints, vigilance reports, and PMCF or PMPF data, must be reviewed to determine whether risk estimates remain valid. Where new hazards or increased risk levels are identified, the risk management file must be updated and appropriate actions taken. Failure to demonstrate this feedback loop is a common regulatory finding.
From a strategic perspective, robust risk management supports proportionate clinical evidence generation and post-market planning. It also provides a defensible basis for benefit-risk conclusions, particularly for higher-risk devices and IVDs.
How Practical RA Can Support
Practical RA supports manufacturers with risk management activities such as:
- Development and review of Risk Management Plans and Reports
- Hazard identification and risk analysis aligned with ISO 14971
- Benefit-risk assessment and justification
- Traceability between risk management, clinical evaluation, and PMS
- Review of residual risk acceptability and labelling alignment
Our focus is on producing documentation that is clear, consistent, and defensible from a regulatory review perspective.
