ISO 14155:2020 addresses good clinical practice for the design, conduct, recording, and reporting of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes. The standard covers clinical investigation planning, ethics committee review, informed consent, sponsor and investigator responsibilities, monitoring, adverse event reporting and the clinical investigation report. The 2020 edition added risk-based monitoring, registration of investigations in public databases and guidance on post-market clinical studies. It is harmonised under the EU MDR, and FDA recognizes it, while US investigations must also meet 21 CFR Parts 50, 56 and 812.

Why it matters

ISO 14155 is the device-specific counterpart to ICH-GCP and is referenced by EU MDR clinical investigation requirements.

Common pitfalls

•Failing to update clinical investigation procedures to align with the 2020 revision of ISO 14155 can lead to non-compliance.
•Applying pharmaceutical good clinical practice (GCP) guidelines directly to MedTech without considering the specific nuances of ISO 14155 can result in inefficient or inappropriate study designs.
•Neglecting the ethical considerations and subject protection requirements detailed in ISO 14155 can lead to regulatory enforcement actions and reputational damage.
•Not adequately training investigators and site staff on ISO 14155 principles can compromise data quality and subject safety.
•Incorrectly managing clinical investigation data according to ISO 14155 can invalidate study results for regulatory submissions.

Sources

ISO 14155:2020 · ISO
AAMI Standards · AAMI
FDA Recognized Consensus Standards · 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

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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.