IEC 62304 configuration management of release artifacts and existing build pipeline controls over released software packages.
Cryptographic integrity verification mechanism (hash or digital signature) for all release executables and security-relevant files, plus HSM or equivalent controls protecting code signing private keys.
Release integrity verification evidence and key management procedure — unsigned releases or undocumented key custody are major findings; secure boot and rollback capability also reviewed.
Maps to
IEC 81001-5-1: §5.8.3 File INTEGRITY
Requirement text
The manufacturer shall establish an activity (or activities) to provide an integrity verification mechanism for all scripts, executables and other security-relevant files used with a health software (5.8.3). Common methods include cryptographic hashes and digital signatures. The manufacturer shall have procedural and technical controls in place to protect private keys used for code signing from unauthorized access or modification (5.8.4).
Why this clause exists
A release artifact — the software binary or firmware image distributed to customers — that can be modified in transit or at rest, without detection, destroys the assurance that all preceding security development activities were intended to provide. If an attacker can substitute a modified binary for the legitimate release, the threat model is irrelevant, the penetration test results are irrelevant, and the secure coding standard is irrelevant: the device is running untrusted code. Cryptographic file integrity controls and private key management discipline are the mechanisms that prevent this attack. IEC 81001-5-1:2021 clauses 5.8.3 and 5.8.4 require both that file integrity of release artifacts be verified using cryptographic methods and that private keys used to sign releases be protected with appropriate key management controls. The two requirements are inseparable: a secure signing key with no integrity verification leaves distribution unprotected; file integrity verification with a compromised signing key provides false assurance. Medical device firmware signing has become a high-value target specifically because a signed firmware implant can bypass integrity checks if the signing key is compromised.
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 release integrity not verifiable by operators — Released software packages are not digitally signed, or signing keys are not properly managed. Operators cannot verify that installed software has not been tampered with. Plans must address secure boot, signed firmware, and rollback capabilities.