Affiliation:
1. Department of Genetics , UMC Utrecht, Utrecht University , Utrecht , the Netherlands
2. Central Diagnostic Laboratory , UMC Utrecht, Utrecht University , Utrecht , the Netherlands
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.
Subject
Biochemistry (medical),Clinical Biochemistry,General Medicine
Reference17 articles.
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3. 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.
4. 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_guidance_qualification_classification_software_en_0.pdf.
5. 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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