IEC 62304 software item inventory, SOUP identification, and software development plan listing component categories.
Three-tier classification of each software item as maintained, supported, or required software, determining post-market security responsibility and update obligations per ISH1:2025.
SBOM annotated with Annex A.3 classification per component — misclassification of SOUP as required software to avoid patching obligations is a major non-conformity.
Maps to
IEC 81001-5-1: §4.3 SOFTWARE ITEM classification relating to risk transfer
ISO 13485: §7.4 Purchasing
Requirement text
The manufacturer shall document which software item is: (a) maintained software — for which the manufacturer will assume the risk related to security (§3.21); (b) supported software — for which the manufacturer will notify the customer regarding known risks related to security (§3.36); or (c) required software — for which the manufacturer will consider security-related risks known before release of the health software (§3.25). This classification determines the manufacturer's level of security responsibility for each software item (see Annex A.3).
Why this clause exists
The three-tier software item classification introduced by IEC 81001-5-1:2021 clause 4.3 — maintained, supported, and required — exists because the manufacturer's post-market security responsibility fundamentally differs based on whether the software item can receive updates under the manufacturer's direct control. Maintained software the manufacturer updates directly; supported software the manufacturer monitors and notifies operators about but the operator updates; required software the manufacturer cannot update and must account for as a fixed-exposure item. Without this classification, manufacturers either claim unlimited post-market responsibility for COTS software they cannot actually patch, or disclaim responsibility for components they do control. The ISH1:2025 Interpretation Sheet clarified the boundary between categories after early implementers misused the 'required software' classification to avoid post-market monitoring obligations for SOUP components that actually could receive security updates. The SBOM is the natural carrier for this classification — each component row should indicate its tier, creating a machine-readable record of who is responsible for its security throughout the product's lifetime. FDA's expectation of SBOM disclosure under Section 524B(b)(1) makes this classification publicly visible in the submission.
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)
- Software classification misused to avoid patching responsibility — Manufacturers misclassify SOUP as 'Required Software' (no updates possible) to avoid post-market patching responsibility. The ISH1:2025 interpretation sheet clarified three categories: maintained (manufacturer provides updates), supported (operator manages updates), and required (updates may be unavailable). Correct classification defines who is responsible for post-market security monitoring.