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Recommendations for IVDR compliant in-house software development in clinical practice: a how-to paper with three use
Hanneke W M van Deutekom1, Saskia Haitjema2
1Department of Genetics, UMC Utrecht, Utrecht University, Utrecht, the Netherlands.
Objectives:
The In Vitro Diagnostics Regulation (IVDR) will be effective in May 2022 by which in-house developed tests need to apply to the general safety and performance requirements defined in Annex I of the IVDR ruling. Yet, article 16 from Annex I about software can be hard to interpret and implement, particularly as laboratories are unfamiliar with quality standards for software development.
Methods:
In this paper we provide recommendations on organizational structure, standards to use, and documentation, for IVDR compliant in-house software development.
Results:
A practical insight is offered into novel standard operating procedures using three examples: an Excel file with a formula to calculate the pharmacokinetics of tacrolimus and to calculate the new dose, a rule for automated diagnosis of acute kidney injury and a bioinformatics pipeline for DNA variant calling.
Conclusions:
We recommend multidisciplinary development teams supported by higher management, use of ISO-15189 in synergy with IEC-62304, and concise documentation that includes intended purpose, classification, requirement management, risk management, verification and validation, configuration management and references to clinical or performance evidence.
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