Maps to
IEC 81001-5-1: §5.3.3
Requirement text
The manufacturer shall implement an architectural review of the health software with respect to behavior under adverse conditions, covering: a) effective segregation of software items; b) the secure design best practices (see 5.3.2); and c) potential security flaws introduced by the architecture. The manufacturer shall document and implement the architectural design review.
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
- •An architectural design review must be conducted and documented.
- •The review must assess effective segregation of software items.
- •The review must assess application of secure design best practices from 5.3.2.
- •The review must assess potential security flaws introduced by the architecture itself.
- •The review must be implemented (findings must be actioned, not merely recorded).
Common gaps
Architecture review lacks independent security perspective
moderateArchitectural design reviews are conducted by the development team without participation from personnel with security expertise. Reviews focus on functional correctness and performance rather than resistance to attack.
Evidence signals
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FILE_EXISTS
Architecture.*Review|Security.*Review.*Record|Architectural.*Design.*Review
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CONTENT_MATCH
Does this document record an architectural design review covering software item segregation, secure design best practices, and security flaws potentially introduced by the architecture, with findings documented and resolved?
Audit defense
The Architectural Design Review record for [your product] (Doc ID: [your document ID]) documents the formal review covering software item segregation, secure design best practices per 5.3.2, and architectural security flaws. All findings were logged in the problem resolution process and tracked to closure.