Maps to
IEC 62304: §9.2
IEC 81001-5-1: §9.3
Requirement text
Investigate vulnerabilities in a timely manner to determine: a) applicability to the product, b) verifiability, c) related threats.
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
- •Vulnerabilities SHALL be investigated in a timely manner.
- •Investigation SHALL determine applicability of the vulnerability to the product.
- •Investigation SHALL determine verifiability of the vulnerability.
- •Investigation SHALL identify related threats.
- •The timeliness requirement means that defined maximum response windows must be established for initial triage of vulnerability reports, differentiated by severity (e.g., critical vulnerabilities require initial triage within a shorter defined period than low-severity findings).
- •Vulnerability review must be performed at planned intervals after product release, not only in response to externally reported issues — this is a proactive periodic review obligation, not only reactive handling.
- •Planned interval reviews must include monitoring of public vulnerability databases (e.g., NVD, CVE) and SOUP vendor advisories for components in the product's SBOM.
- •The review process must be documented and records retained showing the date of review, components checked, findings, and disposition for each review cycle.
Common gaps
Vulnerability triage lacks severity-based response timelines
majorWhen vulnerabilities are reported, there is no defined triage process with severity-based response timelines. All vulnerabilities receive the same priority (or none), leading to critical vulnerabilities languishing alongside minor findings.
Evidence signals
- •
FILE_EXISTS
Vulnerability.*Triage|Security.*Review.*Procedure|Vulnerability.*Assessment|PSIRT.*Process
- •
CONTENT_MATCH
Does this document describe a process for reviewing incoming vulnerability reports to determine whether they apply to the product, whether they can be reproduced or verified, and what related threats they represent?
Audit defense
Our Vulnerability Review Procedure (Doc ID: [your document ID]) requires timely triage of all received vulnerability reports for [your product], with documented determinations of applicability, verifiability, and related threats. Triage records serve as the input to the vulnerability analysis process and are retained in the security file.