The Manufacturer Disclosure Statement for Medical Device Security (MDS2), maintained by the Healthcare Information and Management Systems Society (HIMSS) and aligned to IEC 80001-2-2, is a standardized questionnaire that manufacturers complete to disclose a connected device's security characteristics - authentication, encryption, audit controls, malware protection, network configuration, patch policy - to hospital procurement and security teams.

Why it matters

MDS2 sits at the manufacturer-HDO handoff and is one of the highest-leverage documents a security program produces. A well-completed, current MDS2 directly accelerates hospital procurement; a stale or incomplete MDS2 stalls deals. Mature MedTech teams maintain MDS2 as a living document tied to each release.

Common pitfalls

•Treating MDS2 as a marketing document - overstating capabilities backfires in operator audits.
•Letting MDS2 go stale across releases.
•Not aligning MDS2 to MDS2-2019 (the current version) - older versions miss key security characteristics.

Sources

HIMSS MDS2 · HIMSS
IEC TR 80001-2-2 · ISO/IEC
HSCC - Health Sector Coordinating Council · HSCC

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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.