As per Article 88 of EU MDR manufacturers must analyze and report any statistically significant increase in
- non-serious incidents
- expected undesirable side effects
that could negatively impact the benefit-risk balance and pose unacceptable risks to health or safety. This increase should be assessed against the expected frequency or severity for the device over a defined period.
Why is this important?
- Proactive Safety Monitoring: MDR shifts from reactive to proactive safety evaluation.
- Data Analytics: Manufacturers need robust tools and statistical methods for early detection of trends.
- Audit Focus: Notified Bodies are increasingly scrutinizing trend analysis during audits.
- Integration with PMS & PMCF: Trend analysis must be integrated with PMS plans and feed into Periodic Safety Update Report (PSUR) or PMS reports.
- Cross-functional Challenge: It involves coordination between clinical, regulatory, quality, and data analysis teams.
What needs to be done?
- Set up well-defined procedures for managing incidents within your organization, and specify the observation period to support thorough and effective monitoring
- Develop a clear method for evaluating statistical significance using available data
- Define clear thresholds and statistical methods, and where possible automate signal detection
- Monitor, record and analyze any complaints or incidents related to the medical device. If there is a statistically significant increase, this should be reported
- Integrate the findings in the PSUR or PMS report
What happens once a report is submitted?
- Competent authorities may conduct their own assessments of trend reports, which may require the manufacturer to implement appropriate measures to ensure the protection of public health and patient safety.
- Each competent authority shall inform the Commission, other competent authorities, and the notified body that issued the certificate of the results of such assessments and any measures adopted.
In conclusion, trend reporting under the EU MDR is a critical post-market surveillance (PMS) requirement, driven by stricter obligations and a proactive approach to identifying potential risks. By detecting emerging issues early and responding with appropriate measures, manufacturers not only ensure regulatory compliance but also reinforce their commitment to continuous improvement and public health protection. A well-defined trend reporting process, integrated into the broader PMS system, is essential for maintaining the benefit-risk balance throughout the device lifecycle.
For more details, Contact RN Consulting Solutions MedTech Compliance Experts
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