Maps to
IEC 62304: §8.1
IEC 81001-5-1: §8
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.
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 64 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 #13-112 in December 2022 and references it as providing a framework for the Secure Product Development Framework (SPDF) required by Section 524B.
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.
Atomic constraints
- •A configuration management process SHALL exist covering product development, maintenance, and support.
- •Configuration management SHALL include change controls.
- •Configuration management SHALL include a change history.
- •For released health software, configuration management SHALL enable reproduction of the list of included external components susceptible to vulnerabilities.
Common gaps
Configuration management does not track security-relevant items
moderateSCM 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.'
Evidence signals
- •
FILE_EXISTS
SBOM|Software.*Bill.*of.*Materials|Configuration.*Management|Component.*Inventory|Change.*History
- •
CONTENT_MATCH
Does this document describe or contain a list of external software components included in the product, with version information sufficient to assess vulnerability exposure?
Audit defense
Our configuration management records for [your product] (Doc ID: [your document ID]) include a versioned SBOM for each released build, enabling reproduction of the external component list required by IEC 81001-5-1 §8. Change control records demonstrate that component updates are tracked with full change history.