IEC 62304 change control and configuration management covering source code repositories and build artifacts.
Risk-based procedural and technical controls for development infrastructure — CI/CD pipeline security, protected branches, signed commits, and artifact integrity covering design through release.
Development environment security policy with documented access controls for build infrastructure — undocumented dev environment controls are a moderate but consistent finding.
Maps to
IEC 81001-5-1: §5.1.2 Development environment SECURITY
Requirement text
The manufacturer shall establish risk-based procedural and technical controls for protecting the IT infrastructure used for development, production delivery, and maintenance from unauthorized access, corruption, and deletion. This includes protecting the health software during design, implementation, updates, testing, and release.
Why this clause exists
The development environment is itself an attack surface: a compromised build server can inject malicious code into compliant-looking software; a developer workstation with unrestricted internet access can become a malware vector into the codebase; a build system that does not verify dependency integrity can silently introduce vulnerable components. These scenarios are not hypothetical — supply-chain attacks via compromised build infrastructure have affected commercial software distributed globally. IEC 81001-5-1:2021 clause 5.1.2 requires manufacturers to document and implement security controls for the development environment specifically because the build infrastructure mediates the integrity of the software artifact. For medical device software, a compromised build is particularly consequential: a device that passes all security testing but was compiled from a tampered codebase provides none of the expected assurance. FDA's 2023 cybersecurity guidance references build environment integrity as part of the software supply chain security obligations that premarket submissions must address.
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 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.
Common gaps (what we see in audits)
- Development environment security controls undocumented — Organizations secure production environments but neglect to document and enforce security controls for development environments — source code repositories, CI/CD pipelines, build servers, and developer workstations. Compromised development environments can inject vulnerabilities into released software.