Researchers at the University Medical Center Oldenburg have developed an innovative digital tool that helps clinical laboratories meet the strict requirements of the EU Regulation on In Vitro Diagnostic Medical Devices (IVDR). The publication “IVDCheckR – simplifying documentation for laboratory developed tests according to IVDR requirements by introducing a new digital tool” describes a web-based open source tool that simplifies the documentation of laboratory-developed tests (LDTs) and promotes regulatory compliance. The work was recently published in the journal Clinical Chemistry and Laboratory Medicine and was the subject of an application for the Digital Laboratory Award 2025 of the German Society for Clinical Chemistry and Laboratory Medicine (DGKL).

The EU Regulation (EU) 2017/746 (IVDR), which has been gradually implemented since 2022, poses significant challenges for laboratories. It calls for comprehensive documentation for LDTs – i.e. tests that are developed in-house or modified on CE-marked assays. These include changes such as the extension of measurement intervals, adjustments to dilution processes or the use of unvalidated sample materials. Many laboratories are struggling with the complexity of the regulations due to a lack of user-friendly guidelines and tools. This leads to uncertainties in compliance with safety and performance standards, which ultimately affect patient safety.

Under the direction of Dr. Yadwinder Kaur and the corresponding author Daniel Rosenkranz from the Institute of Clinical Chemistry and Laboratory Medicine at the University Medical Center Oldenburg, IVDCheckR was developed as a solution. The tool is based on the R programming language and the Shiny framework, which enables interactive web applications. It is open-source, system-independent and accessible free of charge at https://kc.uol.de/ivdcheckr/. The source code is available on GitHub (https://github.com/kola8513/IVDCheckR) and uses packages such as shinydashboard, rmarkdown and mcr for statistical analysis.

The core features of IVDCheckR include:

• Project description for LDTs: A structured template with 15 fields covering aspects such as measurand, intended use, scientific validity, sample material and risk classification. Hyperlinks to IVDR references make it easier to find your way around.
• Method Comparison (MC Tool): Allows the comparison of original and modified methods using Passing-Bablok regression and Bland-Altman analysis. Users can enter data interactively and generate graphics.
• Quality Control (QC Tool): Evaluates precision and accuracy by calculating mean, coefficient of variation (CV), root mean square deviation (RMSD), and bias. It distinguishes between within-run and between-run imprecision.
• Other modules: Recording of chemicals, software and declarations of conformity, with export as PDF report.

The developers emphasize that IVDCheckR not only reduces the administrative burden, but also increases transparency, reliability and validity of test results. It serves as a bridge between clinical requirements and regulatory obligations, especially for modifications to CE-marked tests. The publication highlights that LDTs are indispensable in scenarios such as the COVID-19 pandemic or rare diseases, but must now be strictly documented under IVDR.

In her application for the DGKL Advancement Award, Kaur argued that IVDCheckR is a prime example of digitization and process optimization in the modern laboratory. It lowers the hurdles to IVDR compliance and contributes to a uniformly high quality in the laboratory community, which ultimately improves patient safety.

The authors – including experts from Oldenburg and Lübeck – see IVDCheckR as a contribution to digital transformation in laboratory medicine. Developed without financial support or conflicts of interest, the tool stands for collaborative open source innovation. Experts expect similar tools to become standard in the future in order to master the transition periods of the IVDR (until 2028).

The complete publication is available under DOI 10.1515/cclm-2024-0477.

With this work, Yadwinder Kaur is the winner of the Digital Laboratory Award of the DGKL. The award ceremony will take place this evening as part of the MedLab Awards in Leipzig.

You can also read our article about the second winner in the Digital Laboratory Sponsorship Award category:

AI at expert level: New model detects M-proteins in serum protein electrophoresis – MedLabPortal

Further information:

MedLabAwards – MedLabPortal

Editor: X-Press Journalistenbüro GbR

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