ICH E6(R3) provides an internationally accepted standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials, ensuring data credibility and subject protection. E6(R3), adopted by ICH in January 2025, reorganizes the guideline around principles, quality by design and risk-proportionate approaches, and is written to fit decentralized elements and digital data sources. ICH E6 is written for drug trials; device investigations follow ISO 14155, which aligns closely with GCP principles. FDA and the EMA both reference ICH E6 in their guidance.

Why it matters

While developed for drug trials, GCP principles are widely applied to device clinical investigations alongside ISO 14155.

Common pitfalls

•Failing to recognize that ICH E6, while primarilyfor drug trials, is a foundational document influencing medical device clinical investigation expectations.
•Assuming that adherence to ICH E6 alone is sufficient for medical device trials without considering device-specific standards like ISO 14155.
•Overlooking the criticality of a robust quality management system, as outlined in ICH E6, for all clinical trial activities.

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.