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.
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 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)(3) 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 recognized it as Consensus Standard 13-122 (date of entry December 19, 2022). FDA's February 2026 cybersecurity guidance, Section V, lists IEC 81001-5-1 among the "possible frameworks to consider" for secure product development, and FDA's recognition record for the standard notes that conformance "may not satisfy all the cybersecurity requirements outlined in Section 524B of FD&C Act".
EU MDR harmonization was originally targeted for May 2024 but postponed to May 2028.
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. Correct classification defines who is responsible for post-market security monitoring.