The International Medical Device Regulators Forum (IMDRF) Cybersecurity Working Group has published a series of guidance documents - most notably IMDRF/CYBER WG/N60 (Principles and Practices for Medical Device Cybersecurity, 2020) and N73 (Principles and Practices for the Cybersecurity of Legacy Medical Devices, 2023) - that harmonize regulator expectations across jurisdictions including the FDA, Health Canada, MHRA, TGA, PMDA, and the EU.

Why it matters

MedTech teams pursuing global submissions use IMDRF principles as the common backbone, then layer on jurisdiction-specific requirements (524B for the US, MDCG 2019-16 for the EU). The legacy-device guidance (N73) is particularly valuable because it addresses devices designed before modern cybersecurity expectations existed.

Common pitfalls

•Treating IMDRF guidance as the ceiling rather than the floor - national regulators add specifics.
•Ignoring N73's legacy-device guidance for products approaching end-of-support.

Sources

IMDRF/CYBER WG/N60 (2020) · IMDRF
IMDRF/CYBER WG/N73 (2023) · IMDRF
FDA - Cybersecurity for Medical Devices · FDA

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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.