A legacy medical device is one that cannot be reasonably protected against current cybersecurity threats - typically because the underlying OS or platform is unsupported (e.g., Windows XP/7, embedded RTOS without update path), the device cannot accept patches, or the manufacturer has ended support. IMDRF/CYBER WG/N73 (2023) defines the term and frames a shared-responsibility model among manufacturers, healthcare delivery organizations (HDOs), and other stakeholders.

Why it matters

Legacy devices are ubiquitous in hospitals - imaging systems, infusion pumps, lab analyzers - and are repeatedly implicated in ransomware incidents. The right response is a documented end-of-life plan, transparent communication to operators, and a path to a supported replacement, not silent obsolescence.

Common pitfalls

•Letting devices age into legacy status without notifying operators or providing compensating-control guidance.
•Assuming HDO network segmentation alone substitutes for manufacturer responsibility.
•Continuing to sell new units of a device that can no longer be patched.

Sources

IMDRF/CYBER WG/N73 (2023) · IMDRF
FDA Cybersecurity Guidance (Sept 2023) · FDA
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.

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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.