Department of Genetics, UMC Utrecht, Utrecht University, Utrecht, the Netherlands.
Central Diagnostic Laboratory, UMC Utrecht, Utrecht University, Utrecht, the Netherlands.
Clin Chem Lab Med. 2022 May 11;60(7):982-988. doi: 10.1515/cclm-2022-0278. Print 2022 Jun 27.
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.
诊断法规（IVDR）将于 2022 年 5 月生效，届时内部开发的测试需要适用于 IVDR 裁决附件 I 中定义的一般安全性和性能要求。然而，附件 I 中关于软件的第 16 条很难解释和实施，特别是因为实验室不熟悉软件开发的质量标准。
本文为符合 IVDR 要求的内部软件开发展示了组织结构、使用的标准和文档方面的建议。
提供了使用三个示例的新型标准操作程序的实用见解：一个包含公式的 Excel 文件，用于计算他克莫司的药代动力学和计算新剂量、用于自动诊断急性肾损伤的规则以及用于 DNA 变异调用的生物信息学管道。
我们建议由高层管理支持的多学科开发团队，使用与 IEC-62304 协同的 ISO-15189，并进行简洁的文档记录，包括预期用途、分类、需求管理、风险管理、验证和确认、配置管理以及对临床或性能证据的引用。
