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. 2022 May 11;60(7):982-988.
doi: 10.1515/cclm-2022-0278. Print 2022 Jun 27.

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

Hanneke W M van Deutekom  1 , Saskia Haitjema  2
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Free article

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

Hanneke W M van Deutekom et al. Clin Chem Lab Med. .
Free article

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.

Keywords: in vitro diagnostics regulation (IVDR); medical device software; quality management; software development.

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References

    1. European Union. In vitro diagnostic regulation; 2017 [Internet]. Available from: https://eur-lex.europa.eu/eli/reg/2017/746/oj.
    1. European Commission. Progressive roll-out of the in vitro diagnostic medical devices regulation; 2021 [Internet]. Available from: https://ec.europa.eu/commission/presscorner/detail/en/ip_21_6965.
    1. Medical Device Coordination Group. Is your software a medical device; 2021 [Internet]. Available from: https://ec.europa.eu/health/system/files/2021-03/md_mdcg_2021_mdsw_en_0.pdf.
    1. Medical Device Coordination Group. Guidance on qualification and classification of software in regulation (EU) 2017/745 – MDR and regulation (EU) 2017/746 – IVDR; 2019 [Internet]. Available from: https://ec.europa.eu/health/system/files/2020-09/md_mdcg_2019_11_guidanc....
    1. Bank, PCD, Jacobs, LHJ, van den Berg, SAA, van Deutekom, HWM, Hamann, D, Molenkamp, R, et al.. The end of the laboratory developed test as we know it? Recommendations from a national multidisciplinary taskforce of laboratory specialists on the interpretation of the IVDR and its complications. Clin Chem Lab Med 2021;59:491–7. [Internet]. Available from: http://www.ncbi.nlm.nih.gov/pubmed/33554568.

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