IEC 81001-5-1 §8

IEC 81001-5-1: §8 Software CONFIGURATION MANAGEMENT PROCESS

IEC 62304: §8.1 Configuration identification

Software configuration management for security is not simply version control: it is the discipline of ensuring that every security-relevant change to the codebase, the build configuration, the dependency set, or the deployment configuration is identified, evaluated for security impact, controlled through an approval process, and traceable from requirement to implementation to release. Without configuration management discipline, security development activities that were compliant at their completion can be undermined by subsequent uncontrolled changes — a dependency update that introduces a vulnerable version, a configuration change that disables a security control, a code change that reverts a security fix. IEC 81001-5-1:2021 clause 8 requires configuration management to specifically cover security-relevant items and to maintain the integrity of the security development lifecycle outputs. The change history requirement is particularly important for security: when a vulnerability is discovered post-market, the ability to trace when and why each relevant code and configuration change was made is essential for determining root cause and assessing which deployed versions are affected.

IEC 81001-5-1:2021 is the first standalone cybersecurity standard purpose-built for health software and medical device software. Published in December 2021, it was adapted from IEC 62443-4-1 (industrial control systems security) to address the unique safety and regulatory context of medical devices — adding health-specific requirements that account for patient safety, clinical workflows, and the manufacturer-HDO relationship.

The standard mirrors IEC 62304's lifecycle structure but adds security-specific activities at every phase — planning, development, testing, release, and maintenance. It requires security risk management to be integrated with ISO 14971 safety risk management, not treated as a separate IT concern. FDA formally recognized it as Consensus Standard 13-122 on December 19, 2022 and references it as providing one acceptable framework for satisfying the cybersecurity requirements of Section 524B(b)(2), which requires manufacturers to design, develop, and maintain processes and procedures to provide a reasonable assurance that cyber devices and related systems are cybersecure.

EU MDR harmonization was originally targeted for May 2024 but postponed to May 2028. Despite this delay, Notified Bodies and Competent Authorities universally recognize it as "state of the art" for health software cybersecurity under MDR GSPR Annex I, Section 17.2. Missing or inadequate cybersecurity documentation is already a top cause of Notified Body major non-conformities for SaMD. A December 2025 Interpretation Sheet (ISH1:2025) clarified software item classification into maintained, supported, and required software categories, affecting risk transfer and post-market obligations.