IEC 62304 §8.1 configuration identification, change control, and change history already required for software lifecycle management.
SBOM under version control per released product build, enabling reproduction of the external component list for vulnerability exposure assessment when new CVEs are published.
Versioned SBOM linked to each release configuration — configuration management systems tracking source code without SBOM artifacts fail the external-component-reproduction requirement.
Maps to
IEC 81001-5-1: §8 Software CONFIGURATION MANAGEMENT PROCESS
IEC 62304: §8.1 Configuration identification
Requirement text
Establish a general product development, maintenance, and support process that includes configuration management with change controls and change history. For security obligations with health software already released or in the market, configuration management shall provide the capability to reproduce a list of included external components that are or could become susceptible to vulnerabilities.
Why this clause exists
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.
What changed
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 recognized it as Consensus Standard 13-122 (date of entry December 19, 2022). FDA's February 2026 cybersecurity guidance, Section V, lists IEC 81001-5-1 among the "possible frameworks to consider" for secure product development, and FDA's recognition record for the standard notes that conformance "may not satisfy all the cybersecurity requirements outlined in Section 524B of FD&C Act".
EU MDR harmonization was originally targeted for May 2024 but postponed to May 2028.
Common gaps (what we see in audits)
- Configuration management does not track security-relevant items — SCM processes track source code and build artifacts but not security-relevant configuration items — cryptographic keys, certificates, security policy files, access control lists, and hardening configurations. For cloud-deployed SaMD, SOUP dependencies like cloud APIs change outside the manufacturer's control, causing 'version drift.'