IEC 62304 SOUP identification, software item inventory, and existing vulnerability assessment activities for third-party components.
Formal security risk identification and management activity for all required software items, with SBOM-based CVE monitoring and pre-adoption security gate for new components.
SBOM with security risk disposition per component — components adopted without security assessment prior to integration are a major finding under ISH1:2025.
Maps to
IEC 81001-5-1: §5.2.3 SECURITY risks for REQUIRED SOFTWARE
Requirement text
The manufacturer shall establish an activity (or activities) that identifies and manages the security risks of all required software.
Why this clause exists
Required software — components that cannot receive security updates because the vendor does not provide them, because the device cannot be patched in the field, or because updates would require regulatory re-submission — represents a category of fixed security exposure that organizations frequently fail to explicitly account for. When a required software component contains a known vulnerability that cannot be patched, the manufacturer cannot treat it as 'deferred to next release': the vulnerability will be present in every deployed instance of the product indefinitely. IEC 81001-5-1:2021 clause 5.2.3 requires that security risks known before release for required software items be explicitly addressed in the security requirements — meaning compensating controls must be specified as security requirements before development completes, not managed informally. The SBOM classification from clause 4.3 provides the input: components classified as required software trigger this specific requirements activity. FDA inspectors have found numerous cases where manufacturers filed required software in the SBOM without corresponding compensating control requirements or residual risk documentation.
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 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 13-122 on December 19, 2022 and references it as providing one acceptable framework for satisfying the cybersecurity requirements of Section 524B(b)(2), which requires manufacturers to design, develop, and maintain processes and procedures to provide a reasonable assurance that cyber devices and related systems are cybersecure.
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.
Common gaps (what we see in audits)
- Third-party component security risks not assessed before adoption — Manufacturers integrate third-party components without evaluating their security posture, known vulnerabilities, or the supplier's security maintenance commitment. Components are selected based on functionality, not security. Per ISH1:2025, this applies to all three software categories.