Maps to
ISO 13485: §7.2.3
IEC 81001-5-1: §4.1.7
Requirement text
The manufacturer shall establish activities for informing regulatory authorities and product users about vulnerabilities in supported products in a timely manner. Disclosures shall include: vulnerability description, CVSS score (or equivalent ranking system), affected product versions, and description of the resolution.
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
- •An activity (or activities) for disclosing vulnerabilities to regulatory authorities SHALL be established.
- •An activity (or activities) for disclosing vulnerabilities to product users SHALL be established.
- •Disclosures SHALL be made in a timely manner.
- •Disclosures SHALL include a vulnerability description.
- •Disclosures SHALL include a CVSS score or equivalent vulnerability severity ranking.
- •Disclosures SHALL include affected product version(s).
- •Disclosures SHALL include a description of the resolution.
Common gaps
No vulnerability disclosure policy or process
majorManufacturers lack a published vulnerability disclosure policy, have no secure channel for receiving reports, and have no defined process for coordinating with reporters through investigation and remediation. A compliant process requires a defined intake channel, triage timeline (often 72 hours), and communication plan.
Evidence signals
- •
FILE_EXISTS
(Vulnerability.*Disclosure|CVD|Security.*Advisory|Cybersecurity.*Communication|CVSS)
- •
CONTENT_MATCH
Does this document describe a process or record for notifying customers or regulators about product security vulnerabilities, including severity scores and affected versions?
Audit defense
Our vulnerability disclosure procedure (Doc ID: [your document ID]) establishes timely notification to regulatory authorities and product users for [your product], with mandatory inclusion of CVSS scores, affected versions, and resolution descriptions per clause 4.1.7.