Maps to
IEC 81001-5-1: §5.7.2
Requirement text
The manufacturer shall establish an activity (or activities) for testing the effectiveness of the mitigation for the threats identified and assessed in the threat model. Activities shall include: a) creating and executing adequate testing for each mitigation implemented to address a specific threat, in order to ensure that the mitigation works as designed; b) creating and executing plans for attempting to thwart each mitigation; and c) ensuring that the mitigation does not introduce other vulnerabilities to the design.
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
- •Effectiveness of each threat mitigation from the threat model must be tested.
- •Tests must be created and executed for each mitigation to confirm it works as designed.
- •Plans must be created and executed to attempt to thwart each mitigation.
- •Each mitigation must be tested to confirm it does not introduce new vulnerabilities.
Common gaps
Threat model mitigations not verified through testing
majorThreat models identify risks and define mitigations, but testing does not verify that each mitigation is effective. There is no traceability from threat model entries to specific test cases confirming the mitigation works.
Evidence signals
- •
FILE_EXISTS
Threat.*Mitigation.*Test|Mitigation.*Verification|Security.*Test.*Report
- •
CONTENT_MATCH
Does this document describe testing of threat mitigations from the threat model, including tests that confirm mitigations work, attempts to thwart mitigations, and verification that mitigations do not introduce new vulnerabilities?
Audit defense
The Threat Mitigation Test records for [your product] (Doc ID: [your document ID]) document positive and adversarial test execution for each threat model mitigation, confirming effectiveness without introducing new vulnerabilities, per clause 5.7.2.