Recommendations for IVDR compliant in-house software development in clinical practice: a how-to paper with three use cases

Abstract

Abstract 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.