AAMI TIR97:2019/(R)2023, Principles for medical device security: Postmarket risk management for device manufacturers, provides guidance on postmarket security risk management in the ISO 14971 safety-risk-management context and is intended to be used with AAMI TIR57.

Why it matters

TIR97 can inform postmarket risk-management procedures. Claims about required VEX statements, metrics, notification content or deadlines require verification in the licensed report. FDA guidance is now the February 2026 edition.

Common pitfalls

•Do not treat TIR57 or TIR97 guidance as independently binding lifecycle requirements. Assess applicable law and the editions actually used.
•Skipping the patient-safety impact assessment step and defaulting to CVSS, TIR97 expects an explicit linkage between exploitability and harm.
•Document risk-appropriate customer communications; verify any claimed TIR97-specific content or timing against the licensed text.

Sources

AAMI TIR97:2019 · AAMI
FDA Cybersecurity in Medical Devices Guidance (February 2026) · FDA
HSCC - Health Sector Coordinating Council · HSCC
FDA final guidance, February 3, 2026 · FDA

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