Maps to
IEC 81001-5-1: §5.3.1
Requirement text
The manufacturer shall establish an activity (or activities) to specify a secure architecture. At each stage of development, the manufacturer should consider defense-in-depth and assign technical requirements to each layer of defense. When identifying technical security risk controls, the manufacturer shall take into account requirements regarding safety or performance of health 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
- •A secure architecture must be specified and documented.
- •Defense-in-depth must be considered at each stage of development.
- •Technical requirements must be assigned to each layer of defense.
- •When identifying technical security risk controls, safety and performance requirements of the health software must be taken into account.
- •Security architecture diagrams must be produced showing the security zones, trust boundaries, and the controls enforced at each boundary.
- •The defense-in-depth design must assign at least one technical security control at each identified layer (network, application, data, authentication, and endpoint as applicable to the product).
- •The security architecture must explicitly map each security control to the threat(s) it mitigates, providing traceability between the threat model and the architecture.
- •Security controls that could adversely affect clinical safety (e.g., timeouts that interrupt clinical workflows, encryption overhead that affects real-time processing) must be identified and their safety impact assessed and documented.
- •The security architecture must be reviewed and updated whenever the system architecture changes, new attack surfaces are identified, or the threat model is updated.
Common gaps
Single-layer security controls without defense-in-depth
majorManufacturers implement a single security boundary (e.g., authentication at the API gateway) without layered controls at multiple architectural levels. Notified Bodies reject designs that rely solely on a single perimeter defense without internal software item segregation. Defense-in-depth requires controls at network, application, data, and component levels.
Evidence signals
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FILE_EXISTS
Security.*Architecture|Architecture.*Design|Defense.*Depth|Security.*Design.*Document
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CONTENT_MATCH
Does this document describe a layered security architecture with defense-in-depth, assigning security controls to each layer and considering the impact of security controls on safety or performance?
Audit defense
The Security Architecture document for [your product] (Doc ID: [your document ID]) specifies a defense-in-depth architecture with technical security requirements assigned per layer. Each control was reviewed for impact on clinical safety and system performance prior to implementation.