ISO 13485 product lifecycle documentation and IFU requirements covering installation and operational guidance throughout the product’s service life.
Explicit decommissioning section in product documentation covering data sanitization, credential revocation, network isolation, secure media disposal, and HDO notification steps.
Product user documentation with a decommissioning or end-of-life section — absence of decommissioning guidance is a consistent moderate finding for health software products.
Maps to
IEC 81001-5-1: §5.8.7 SECURE decommissioning guidelines for HEALTH SOFTWARE
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.
Why this clause exists
Devices that are decommissioned without removing sensitive data — patient records, credentials, encryption keys, configuration secrets, proprietary clinical algorithms — create a persistent security risk that outlasts the device's operational life. Decommissioned medical devices frequently enter secondary markets, are returned to manufacturers for analysis, or are disposed of through channels that do not guarantee data destruction. A decommissioned infusion pump with retained patient dosing history and network credentials represents a regulatory, privacy, and security violation that is entirely preventable with documented decommissioning procedures. IEC 81001-5-1:2021 clause 5.8.7 requires that accompanying documentation include guidance for secure decommissioning, placing the obligation to produce this guidance on the manufacturer who understands the device's data storage architecture. Operators are frequently unaware of all data storage locations within a medical device — onboard flash, removable media, temporary buffers, logs, cached credentials — and cannot safely decommission without manufacturer guidance that enumerates these locations and specifies effective removal methods.
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)
- No decommissioning guidance for operators — Manufacturers do not provide guidance on secure decommissioning — data sanitization, credential revocation, network isolation, and safe disposal of devices containing patient data or security credentials.