Vulnerability Exploitability eXchange (VEX) is a machine-readable security advisory format that lets a software producer state, for each CVE that appears in their product's SBOM, whether the vulnerability is exploitable in their product ("affected"), not exploitable ("not_affected" with a justification), already fixed, or under investigation. VEX is typically expressed in CycloneDX VEX, CSAF (Common Security Advisory Framework), or OpenVEX formats. CISA publishes the canonical use cases.

Why it matters

Without VEX, every CVE that touches any SBOM component becomes a triage burden for hospitals. With VEX, vendors push the exploitability decision once and operators can filter their device fleet to the truly affected subset. Mature MedTech teams generate VEX as part of the same CI/CD flow that emits the SBOM.

Common pitfalls

•Marking components 'not_affected' without a documented justification - the justification field is the whole value of VEX.
•Publishing VEX once at release and never updating as new CVEs are disclosed against existing components.
•Using inconsistent identifiers (CPE vs PURL vs SWID) that prevent automated matching against the SBOM.

Sources

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Why compare MedTech terms side by side?

MedTech terminology is full of pairs that look interchangeable but carry very different regulatory, clinical, and commercial consequences. Picking the wrong framework, pathway, or standard early in a project can add months to a submission, invalidate clinical evidence, or trigger an audit finding. Side-by-side comparison is the fastest way to surface those differences before they become costly mistakes.

Each comparison on this page pulls from the same vendor-neutral, sourced definitions used throughout the MedTech Terms glossary. You see the one-line summary, the formal definition, why it matters in practice, common pitfalls, and the primary sources (FDA guidance, EU MDR/IVDR articles, ISO/IEC standards, MDCG documents, IMDRF principles) that back each entry. That makes the comparison defensible in regulatory strategy memos, design reviews, and submission narratives.

Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

How to use this tool

Pick term A and term B from the dropdowns, or click a preset above. The URL updates with both slugs so you can bookmark or share the exact comparison with a colleague, a notified body reviewer, or your regulatory consultant. Click Open full page on either side for the complete entry, including FAQs, related terms, and the full citation list. If you are not sure which term to start with, browse the Categories view or the A-Z index.

MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice.