Maps to
ISO 14971: §6.1
IEC 81001-5-1: §7.4
IEC 62443-4-1: §SR-3
Requirement text
Determine whether security risk control measures are appropriate: select mitigations, determine whether mitigations create new risks, implement mitigations, and verify effectiveness. Document results. Handle residual risks in cooperation with the product risk management process.
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 risk control measures SHALL be selected for risks determined to be unacceptable.
- •Each mitigation SHALL be evaluated to determine whether it introduces new risks.
- •Mitigations SHALL be implemented.
- •Effectiveness of mitigations SHALL be verified.
- •Results of risk control activities SHALL be documented.
- •Residual security risks SHALL be handled in cooperation with the product risk management process.
Common gaps
Security controls not verified for effectiveness
majorSecurity risk controls are specified (encryption, authentication, access control) but their effectiveness is not verified through adversarial testing. Controls are assumed to work based on implementation rather than demonstrated through penetration testing and fuzzing.
Evidence signals
- •
FILE_EXISTS
Security.*Risk.*Control|Risk.*Mitigation|Security.*Control.*Verification|Risk.*Management.*File
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CONTENT_MATCH
Does this document describe the selection, implementation, and verification of security risk controls, including an assessment of whether controls introduce new risks and how residual risks are handled?
Audit defense
Our Risk Management File for [your product] (Doc ID: [your document ID]) documents each security risk control measure selected, implementation evidence, and verification test results confirming effectiveness. Secondary risk assessments are included for each control, and residual risks are carried into the ISO 14971 risk-benefit evaluation.