ISO 14155 (Clinical Investigation of Medical Devices for Human Subjects — GCP)

ISO 14155:2020, formally titled “Clinical investigation of medical devices for human subjects — Good clinical practice,” is the International Organization for Standardization’s standard defining the ethical and scientific quality requirements for planning, conducting, recording, and reporting clinical investigations of medical devices in human subjects. It is the device-industry counterpart to ICH E6, which governs drug and biologic trials: a device study is ISO 14155-compliant when its investigation plan, informed-consent process, investigator qualifications, sponsor monitoring, adverse-event and device-deficiency reporting, and clinical investigation report each satisfy the standard’s specified requirements, with the underlying records available for inspection.

Why medical devices needed a GCP standard separate from ICH E6

ICH E6 was written by and for the pharmaceutical/biologic industry and regulators; its text assumes concepts — dosing, pharmacovigilance, drug accountability — that don’t map cleanly onto devices. Medical devices raise distinct issues ICH E6 does not address in any depth: iterative design changes between investigational units, operator/user-interface risk, device-specific risk management (governed by the companion standard ISO 14971), device accountability and reconciliation, and technical performance evaluation alongside clinical safety. ISO 14155 was developed to give device manufacturers, sponsors, investigators, and regulators a GCP framework built around those realities, while preserving the same ethical foundation as ICH E6: independent ethics committee review, documented informed consent, scientifically sound design, and protection of subject rights, safety, and well-being.

Structure and key content of the standard

ISO 14155:2020 (the current edition, published 28 July 2020, superseding the 2011 edition) is organized around the lifecycle of a clinical investigation. Its normative core — Clause 7, “Conduct of a clinical investigation” — sets out requirements sponsors and investigators must meet in sequence, including:

• Clinical investigation plan (CIP) — the device equivalent of a clinical trial protocol, specifying objectives, design, endpoints, statistical methods, and risk-benefit rationale.
• Investigator’s brochure — the pre-clinical and any available clinical data package given to investigators before enrollment begins.
• Ethics committee review and informed consent — independent review and documented, freely-given consent, structured in parallel with (but not identical in required content to) ICH E6’s provisions.
• Sponsor responsibilities — selecting qualified investigators and sites, monitoring, maintaining the trial master file, and device accountability (tracking every investigational device from receipt through use, return, or destruction).
• Adverse event and device deficiency reporting — including reporting of device deficiencies that could have led to a serious adverse event even where no injury actually occurred, a category with no direct ICH E6 parallel.
• Clinical investigation report — the closing summary of conduct, results, and any deviations, structured per the standard’s Annex requirements.

Annexes to the standard provide templates and detailed content requirements for the CIP, investigator’s brochure, informed consent, and the clinical investigation report, functioning similarly to how ICH E6 and ICH E3 structure trial protocols and clinical study reports for drugs.

Regulatory role in the EU: MDR and CE marking

Under the EU Medical Device Regulation (Regulation (EU) 2017/745, “MDR”), manufacturers conducting a pre-market clinical investigation to support CE marking must generate clinical data meeting GCP principles. ISO 14155:2020 is the standard manufacturers and notified bodies most commonly point to as evidence of meeting that GCP expectation, and national competent authorities and ethics committees across the EU, UK, and Switzerland routinely expect investigations to be designed and conducted to it. As of this writing, EN ISO 14155:2020 has not been formally harmonized (listed in the Official Journal) under the MDR the way some other standards have — manufacturers should confirm current harmonization status and any applicable MDCG guidance before relying on the standard alone to demonstrate regulatory conformity.

Regulatory role in the US: FDA recognition and the IDE pathway

The FDA does not mandate ISO 14155 by regulation the way it requires, for example, 21 CFR Part 812 for significant-risk device studies conducted under an Investigational Device Exemption (IDE). Instead, FDA includes ISO 14155:2020 in its FDA-recognized consensus standards database. Practically, this means: sponsors can cite conformance to ISO 14155:2020 as part of demonstrating GCP compliance in IDE applications, and clinical data collected outside the US in investigations conducted to ISO 14155:2020 can, subject to FDA review, support US submissions including IDE applications, 510(k) premarket notifications, De Novo requests, and PMA (premarket approval) applications — letting sponsors leverage a single well-designed international investigation rather than duplicating it region by region.

ISO 14155 vs. ICH E6 — the practical distinction

The two standards share the same ethical DNA but are not interchangeable, and sponsors running combination products or device/drug programs side by side need to track which applies:

• Scope: ISO 14155 covers investigational medical devices; ICH E6 (now at ICH E6(R3)) covers investigational drugs and biologics.
• Risk framework: ISO 14155 incorporates device-specific risk management referencing ISO 14971; ICH E6 has no equivalent device risk-management clause.
• Deficiency reporting: ISO 14155 requires tracking device deficiencies (including near-misses with no patient harm) as a distinct reportable category; ICH E6’s adverse-event framework is oriented around the subject’s clinical experience, not device malfunction independent of harm.
• Primary regulatory anchors: ISO 14155 pairs with the EU MDR and, in the US, with 21 CFR Part 812 (IDE regulations); ICH E6 pairs with ICH’s own regional implementations (FDA, EMA, and other ICH member/observer regulators) for drug and biologic trials.

A drug-device combination product study may need to satisfy elements of both frameworks depending on which regulatory pathway (drug-led or device-led) the product follows — sponsors should confirm the applicable standard(s) with the relevant regulatory authority rather than assume one framework automatically satisfies the other.

Practical implications for research administrators

For institutions and sponsors running device trials, ISO 14155 conformance shapes concrete operational requirements: protocol and case-report-form templates built to the standard’s CIP content requirements, investigator training on device accountability and deficiency reporting (distinct from adverse-event training built around drug trial GCP), monitoring plans that check device handling and reconciliation alongside subject safety data, and clinical investigation reports structured to the standard’s Annex requirements before submission to ethics committees, notified bodies, or FDA. Research administration offices that primarily support pharmaceutical-sponsored trials should not assume their existing ICH E6-based GCP training and templates transfer directly to a device study without this device-specific layer.

Frequently asked questions

Is ISO 14155 the same as ICH GCP?

No. Both are Good Clinical Practice standards built on the same core ethical principles, but ISO 14155 is specific to medical devices while ICH E6 (now ICH E6(R3)) is specific to drugs and biologics. They have overlapping but distinct content requirements, as described above.

Does the FDA require ISO 14155 compliance?

Not by direct regulatory mandate — the binding US regulation for significant-risk device studies is 21 CFR Part 812 (Investigational Device Exemptions). However, FDA recognizes ISO 14155:2020 as a consensus standard, and citing conformance to it is a well-established way to demonstrate GCP compliance in IDE and other device submissions.

Is ISO 14155 mandatory under the EU MDR?

The MDR requires clinical investigations to meet GCP principles; it does not name ISO 14155 as the sole mandatory mechanism, but the standard is the accepted, near-universal way manufacturers demonstrate that GCP expectation to notified bodies and competent authorities. Manufacturers should verify current harmonization status before relying on it alone as proof of regulatory conformity.

What changed between the 2011 and 2020 editions?

ISO 14155:2020 superseded the 2011 edition on 28 July 2020, updating the standard’s requirements and structure to reflect current device-trial practice and align more closely with the EU MDR framework that followed the 2011 edition. Sponsors relying on older training materials or templates referencing the 2011 edition should confirm they have been updated to the 2020 text.

See also: Good Clinical Practice (GCP) Certification, Clinical Trial Phases, and Humanitarian Use Device (HUD) for related device-regulatory concepts.