Maps to
IEC 81001-5-1: §5.2.3
Requirement text
The manufacturer shall establish an activity (or activities) that identifies and manages the security risks of all required software.
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
- •All required software (third-party components, libraries, operating system dependencies) must be identified.
- •Security risks associated with each piece of required software must be identified.
- •Security risks of required software must be managed through the security risk management process.
Common gaps
Third-party component security risks not assessed before adoption
majorManufacturers integrate third-party components without evaluating their security posture, known vulnerabilities, or the supplier's security maintenance commitment. Components are selected based on functionality, not security. Per ISH1:2025, this applies to all three software categories.
Evidence signals
- •
FILE_EXISTS
SBOM|Software.*Bill.*Materials|Third.*Party.*Risk|Supply.*Chain.*Security|Component.*Inventory
- •
CONTENT_MATCH
Does this document identify third-party software components or required software and assess their security risks, including known vulnerabilities or supply chain threats?
Audit defense
The Software Bill of Materials and supply chain security assessment for [your product] (Doc ID: [your document ID]) identifies all required software and documents security risk management activities for each component, ensuring third-party supply chain risks are visible and controlled.