Maps to
IEC 81001-5-1: §5.8.7
Requirement text
The manufacturer shall establish an activity (or activities) to create product user documentation that includes guidelines for removing the health software from use.
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 64 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 #13-112 in December 2022 and references it as providing a framework for the Secure Product Development Framework (SPDF) required by Section 524B.
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
- •Product user documentation must include guidelines for removing the health software from use (decommissioning).
Common gaps
No decommissioning guidance for operators
moderateManufacturers do not provide guidance on secure decommissioning — data sanitization, credential revocation, network isolation, and safe disposal of devices containing patient data or security credentials.
Evidence signals
- •
FILE_EXISTS
Decommission|Uninstall.*Guide|Removal.*Guide|End.*Life|Product.*Documentation
- •
CONTENT_MATCH
Does this document provide guidelines for removing or decommissioning the health software from use, including steps for secure data handling and system removal?
Audit defense
The Product User Documentation for [your product] (Doc ID: [your document ID]) includes a decommissioning section providing guidelines for securely removing the health software from use, satisfying the requirement in clause 5.8.7.