Maps to
IEC 81001-5-1: §5.2.2
Requirement text
The manufacturer shall establish an activity (or activities) for ensuring that security requirements: a) implement product requirements including those relating to risk control; b) do not contradict one another; c) are expressed in terms that avoid ambiguity; and d) are stated in terms that permit establishment of test criteria and performance of tests. The manufacturer shall document the level of independence of the reviewers. Each of the following representative disciplines shall participate: architects/developers, testers, cross-functional/clinical experts, and security advisors.
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
- •Security requirements must implement product requirements including risk control requirements.
- •Security requirements must not contradict one another.
- •Security requirements must be expressed without ambiguity.
- •Security requirements must be stated in terms that permit test criteria to be established and tests performed.
- •The level of independence of reviewers must be documented.
- •Architects/developers must participate in the review.
- •Testers must participate in the review.
- •Cross-functional or clinical experts must participate in the review.
- •Security advisors must participate in the review.
- •The review activity is a requirements review, not a security testing activity — passing this review confirms the security requirements are well-formed, not that the implemented security controls are effective; the latter is security validation per clause 5.6.
- •Review records must document each participant's role, organizational function, and independence level, and must record the disposition of each issue identified during review.
- •Security requirements review must be repeated or re-scoped when security requirements are changed, added, or removed after the initial review.
Common gaps
Security requirements reviewed by same team that wrote them
moderateSecurity requirements are reviewed internally by the same development team without independent security review. Requirements may be technically sound but miss threat scenarios that only a security specialist would identify.
Evidence signals
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FILE_EXISTS
Requirements.*Review|Security.*Review.*Record|Review.*Checklist
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CONTENT_MATCH
Does this document record a multi-disciplinary review of security requirements confirming they are unambiguous, non-contradictory, testable, and implement product/risk control requirements, with reviewer independence documented?
Audit defense
The Security Requirements Review record for [your product] (Doc ID: [your document ID]) documents a multi-disciplinary review covering all four quality criteria, with participants from architecture, testing, clinical/cross-functional, and security advisory functions. Reviewer independence level is documented per clause 5.2.2.