Supporting IVDR Compliance Through Scientific Validity Reports for Diagnostic Analyzers
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Challenge
Approach
Result
Challenge
Regulatory & scientific documentation for IVDR compliance
As part of their efforts to comply with the European In Vitro Diagnostic Regulation (IVDR) 2017/746, our client faced the challenge of generating robust scientific validity documentation for their laboratory analyzers. This required demonstrating the clinical relevance of each analyte measured by the devices, following a systematic approach aligned with IVDR procedures.
Given the broad scope of analytes and specimen types, the client identified the need for an experienced partner with both scientific and regulatory expertise. They turned to Qarad, recognized for its strong track record in IVDR compliance and scientific documentation, to lead the development of their Scientific Validity Reports.
Approach
Structured collaboration to ensure scientific and regulatory robustness
Qarad adopted a structured and collaborative approach to support their client in developing the Scientific Validity Reports.
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Strategic alignment between Qarad and the client’s scientific division to define the scope, group analytes appropriately, and ensure coverage of the most relevant clinical conditions.
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Development of six distinct Scientific Validity Reports, each tailored to a specific analytical focus (e.g., cell type or specimen category). These reports consolidated scientific literature, clinical guidelines, and expert consensus to substantiate the scientific validity and clinical utility of the analyzers.
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Ongoing collaboration and review: Qarad maintained close communication with the client throughout the process to incorporate feedback and meet internal review standards. Once finalized and approved, the reports were submitted to the client.
Result
Comprehensive reports supporting IVDR compliance and long-term partnership
The collaboration resulted in the successful delivery of six comprehensive and IVDR-compliant Scientific Validity Reports. These documents became a key component of the clinical evidence required for IVDR submission, enabling the client to move forward confidently with their regulatory strategy for clinical laboratory analyzers.
Through this project, the strong working relationship between Qarad and their client - established in 2018 - was further strengthened, positioning Qarad as a continued trusted partner for future regulatory and clinical support needs.
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