An analysis not to overlook
Trend reporting is a crucial aspect of complying with MDR and IVDR regulations.
In essence, manufacturers must monitor and report any significant increases in non-serious incidents or foreseeable undesirable side effects that could compromise patient safety.
To meet these requirements, careful post-market surveillance planning is essential. This planning should encompass appropriate indicators and thresholds for the ongoing assessment of benefit-risk analysis.
In partnership with a qualified statistician, we have developed a statistical method based on three-sigma limits tailored for post-market surveillance of MD & IVD to be directly integrated into your system.
(beta tester)
"We often faced challenges during audits regarding trend reporting. The presented method is accessible and can be customized based on the amount of data we have. All the documents guide us in implementing the method. We are well-prepared for the next audit."
RA & QA Manager
"A clear method that not only addresses Article 88 but also links to risk mangement (ISO 14971) and the post-market surveillance system"
Quality manager & QP
As experts in regulatory affairs and/or quality, statistics may not be our primary expertise. That's why we brought in an expert who could tailor the method to our regulatory requirements.
What could be simpler than a procedure/excel file duo to implement directly into your QMS ?
Find in our guide how to adapt our method, whether you have a large or small amount of data to integrate into your trend reporting; our method easily adapts.
"We worked with a statistician who successfully highlighted both a simple and easily implementable statistical method, aligning with the regulatory requirements of trend reporting as mandated by the MDR and IVDR. After several adjustments, we arrived at a fitting adaptation that resonates with the essence of post-market surveillance for MD & IVD."
The offer may evolve based on your feedback and regulatory requirements. Once in your possession, you will receive updates free of charge.
The trend reporting bundle includes a guide that helps you transition from regulatory and statistical theory to practical implementation. It provides actionable advice that is easy to integrate. Additionally, it contains a procedure for inclusion in your Quality Management System (QMS) and an automated, user-friendly trend reporting file (.xlsx) for generating your trend report according to our method.
We are not statistics experts either. We collaborated with a specialized statistical consultant to develop a method that is tailored to regulatory requirements, making it more accessible to those who may not be statistical experts.
We used regulatory text such as MDR 2017/745, IVDR 2017/746, guidance GHTF/SG2/N36R7:2003 - Manufacturer's Trend Reporting and normative standards like ISO/TR 20416:2020 in the development of this method.
Our method combines a well-known quality statistical method adapted to the MDR and IVDR requirements: the 3 sigma method. Beyond meeting trend reporting requirements, our adapted method also addresses post-market surveillance plan requirements concerning the use of indicators and thresholds. We also focus on trend analysis to determine when a "statistically significant increase" occurs and when it should be reported to regulatory authorities.
Like all the documents we provide, examples are included to guide you through the collection, analysis, and accurate interpretation of your data.