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

The 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 a...

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Bibliographic Details
Published inClinical chemistry and laboratory medicine Vol. 60; no. 7; pp. 982 - 988
Main Authors van Deutekom, Hanneke W.M., Haitjema, Saskia
Format Journal Article
LanguageEnglish
Published Germany De Gruyter 27.06.2022
Walter De Gruyter & Company
Subjects
Bioinformatics
Configuration management
Deoxyribonucleic acid
diagnostics regulation (IVDR)
DNA
Documentation
Mathematical analysis
medical device software
Organizational structure
Pharmacokinetics
quality management
Quality standards
Risk management
Software
Software development
Tacrolimus
in vitro diagnostics regulation (IVDR)
quality management
software development
medical device software
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Summary:The 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. In this paper we provide recommendations on organizational structure, standards to use, and documentation, for IVDR compliant in-house software development. 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. 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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ISSN:1434-6621
1437-4331
DOI:10.1515/cclm-2022-0278