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).
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.
Atomic constraints
- •Each software item SHALL be classified as maintained software, supported software, or required software.
- •The classification of each software item SHALL be documented.
- •The classification SHALL be used to determine the manufacturer's security responsibility level for that item.
Common gaps
Software classification misused to avoid patching responsibility
majorManufacturers 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.
Evidence signals
- •
FILE_EXISTS
(SBOM|Software.*BOM|Software.*Item.*Class|Maintained.*Software|Supported.*Software|Required.*Software|Component.*Register)
- •
CONTENT_MATCH
Does this document classify software items or components as maintained, supported, or required software, and document the associated security responsibilities of the manufacturer?
Audit defense
Our software item classification register (Doc ID: [your document ID]) documents each component of [your product] as maintained, supported, or required software per IEC 81001-5-1 clause 4.3 and Annex A.3, making the manufacturer's security responsibilities explicit and traceable.