TY - JOUR
T1 - Recommendations for IVDR compliant in-house software development in clinical practice, a how-to paper with three use cases
AU - van Deutekom, Hanneke W M
AU - Haitjema, Saskia
N1 - Publisher Copyright:
© 2022 Hanneke W.M. van Deutekom and Saskia Haitjema, published by De Gruyter, Berlin/Boston.
PY - 2022/6/27
Y1 - 2022/6/27
N2 - 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.
AB - 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.
KW - Documentation
KW - Humans
KW - Laboratories
KW - Reference Standards
KW - Risk Management
KW - Software
KW - in vitro diagnostics regulation (IVDR)
KW - medical device software
KW - quality management
KW - software development
UR - http://www.scopus.com/inward/record.url?scp=85130532209&partnerID=8YFLogxK
U2 - 10.1515/cclm-2022-0278
DO - 10.1515/cclm-2022-0278
M3 - Article
C2 - 35538674
SN - 1434-6621
VL - 60
SP - 982
EP - 988
JO - Clinical Chemistry and Laboratory Medicine
JF - Clinical Chemistry and Laboratory Medicine
IS - 7
ER -