December 20, 2025

Modern medical devices are increasingly software-driven, interconnected, and exposed to continuous cybersecurity threats. As the industry moves into 2025, Software Bill of Materials (SBOM) has evolved from best-practice documents to a binding regulatory expectation across the FDA, EU, UK, and global markets. Manufacturers are now required to maintain high-fidelity SBOMs, real-time vulnerability intelligence, lifecycle traceability, and secure update mechanisms.

Maven Regulatory Solutions supports manufacturers with complete SBOM governance frameworks, cybersecurity documentation, and global regulatory alignment, ensuring devices remain secure, compliant, and market ready.

Why SBOM Has Become Mandatory

SBOM provides transparency of all third-party, open-source, and proprietary software components inside a medical device. This visibility is essential because:

  • Software supply-chain attacks have increased by >200% since 2021.
  • 78% of vulnerabilities reported in medical devices in 2024 were traced to third-party components.
  • Regulators now require full component attribution, including licenses, versions, and risk status.

SBOM is now a regulatory artifact, not a cybersecurity optional element.

Regulatory Expectations for SBOM in 2025 and Beyond

FDA Requirements Under Section 524B (Cybersecurity in Medical Devices)

FDA now mandates that medical device submissions include:

SBOM Structure Requirements

  • Machine-readable format (SPDX, CycloneDX, SWID).
  • Component name, version, supplier, dependency tree.
  • Known vulnerabilities (NVD, CVE, KEV).
  • License obligations and compliance considerations.

Submission-Level Expectations

  • Complete SBOM for all off-the-shelf (OTS) and open-source software.
  • Evidence of continuous monitoring for vulnerabilities.
  • Integration with Secure Product Development Framework (SPDF).
  • Patch management timeline justification and update process.

Post market Surveillance Integration

  • Ongoing vulnerability detection aligned with FDA’s Post market Cybersecurity Guidance.
  • Real-time risk evaluation using SBOM as the baseline.
  • Documented communication channels for customer risk notifications.

EU MDR, EU Cyber Resilience Act & EN 82304-2 Expectations

As EU cybersecurity regulations tighten, SBOM becomes mandatory for:

  • General Safety & Performance Requirements (GSPR 17, 18)
  • Cybersecurity MDR/IVDR Technical Documentation
  • Coordinated Vulnerability Disclosure (CVD)
  • CRA-required software component transparency
  • EN 82304-2 cybersecurity verification requirements

Manufacturers targeting EU markets require SBOM to demonstrate:

  • Supply-chain cybersecurity risk controls
  • Reliable patching workflows
  • Lifecycle documentation and secure maintenance
  • Transparent open-source license compliance

IMDRF Principles and Global Convergence

Regulatory agencies across Japan, Australia, Singapore, Canada, and UK MHRA are aligning with IMDRF cybersecurity principles requiring:

  • SBOM availability to regulators
  • Evidence of robust software supply-chain controls
  • Integration with risk management (ISO 14971) and QMS (ISO 13485)
  • Unified vulnerability response processes

Core SBOM Technical Elements Manufacturers Must Maintain

SBOM Structural Components

  • Component name and type
  • Version, build number, and supplier
  • Hash identifiers
  • Dependency mapping
  • Package URL (pURL)
  • Vulnerability references (CVE, CWE, CAPEC)
  • License metadata
  • Integrity verification mechanisms

SBOM Regulatory Mapping

Regulatory Domain

Required SBOM Elements

Maven-Ready Deliverables

FDA 524B

Full component inventory, vulnerability disclosure, update process

Submission-ready SBOM + Cybersecurity Documentation Set

EU MDR/Cyber Resilience Act

Transparency of OSS, license compliance, lifecycle security

GSPR cybersecurity mapping, CRA readiness

IMDRF Cybersecurity Principles

SBOM + vulnerability intelligence & lifecycle risk management

Integrated SBOM + Risk Registers

Postmarked Surveillance

Continuous monitoring, KEV alignment, patch timelines

Threat intelligence workflow + Patch justification records

SBOM Lifecycle Management—A 2025 Industry Expectation

Creation and Validation

  • Generated at build time through automated pipelines
  • Verified through cryptographic signing
  • Integrated with CI/CD security scans
  • Attached to Design History File (DHF) and Device Master Record (DMR)

Storage and Distribution

  • Version-controlled storage in the manufacturer’s repository
  • Availability to regulators upon request
  • Secure customer-sharing mechanism for critical updates

Continuous Monitoring

  • Automated linkage of SBOM components to CVE/NVD feeds
  • Real-time exposure scoring
  • Continuous KEV and EPSS monitoring
  • Alerting workflows for vulnerable components

Risk Assessment Integration

  • Direct alignment with ISO 14971 hazard analysis
  • Cybersecurity risk scoring (CVSS-based)
  • Classification of exploitability, severity, and impact
  • Documentation within cybersecurity risk management files

Vulnerability Remediation

  • Patch prioritization based on exploit likelihood
  • Communication strategy for customers and healthcare providers
  • Integration with secure update mechanisms
  • Validation testing evidence (verification + regression reports)

SBOM as a Cybersecurity Evidence Package in Regulatory Submissions

In 2025, SBOM became a central evidence artifact within:

  • Cybersecurity Risk Management Plan
  • Pre-market Submission (510(k), De Novo, PMA, EU MDR Technical File)
  • Threat Modeling Report
  • Secure Design Documentation
  • Patch and Update Strategy
  • Post market Cybersecurity Surveillance Plan

Regulators expect manufacturers to justify:

  • Why each component was selected
  • How vulnerabilities are monitored
  • How quickly patches can be deployed
  • Whether the update mechanism is secure
  • How the device remains safe during vulnerability windows

This requires an end-to-end SBOM governance framework, which Maven provides through structured documentation, lifecycle workflows, and compliance-ready templates.

Best-Practice SBOM Governance Framework for 2025

Governance Foundation

  • Clear ownership between R&D, cybersecurity, and regulatory affairs
  • SBOM policies aligned with QMS and SPDF
  • Component approval workflows
  • Supplier evaluation controls

Automated SBOM Generation

  • Build-level SBOM extraction
  • Dependency resolution
  • De-duplication and normalization
  • Delta comparison tracking for new software releases

Vulnerability Intelligence

  • Automated mapping to CVE, NVD, CISA KEV
  • Real-time zero-day flagging
  • Patch feasibility scoring
  • Exposure-likelihood modeling

Compliance Documentation

  • SBOM included DHF, Risk Management File, and Technical File
  • End-to-end traceability logs
  • Update and remediation documentation
  • Regulatory communication logs

How Maven Regulatory Solutions Helps Manufacturers Achieve SBOM Excellence

Maven provides complete SBOM compliance support, including:

  • End-to-end SBOM development
  • Regulatory submission formatting (FDA, EU MDR, IMDRF)
  • Vulnerability intelligence reporting
  • Patch and update workflow documentation
  • Threat modeling and cybersecurity risk management
  • QMS integration for SBOM governance
  • Global adherence to 524B, CRA, MDR/IVDR, IMDRF
  • Audit and inspection readiness support

Our team ensures manufacturers achieve transparent software supply chains, secure lifecycle maintenance, and full cybersecurity compliance.