ISO 14155 is the international standard that defines Good Clinical Practice (GCP) for clinical investigations of medical devices in human subjects. It sets requirements for the design, conduct, recording, and reporting of clinical studies for devices to protect participants and produce credible safety and performance data that regulators can rely on.
What is ISO 14155?
ISO 14155 is published by the International Organization for Standardization (ISO) and carries the full title “Clinical investigation of medical devices for human subjects, Good clinical practice.” It applies to both pre-market and post-market clinical investigations and centers on the responsibilities of the sponsor and the principal investigator.
The current edition is the fourth, ISO 14155:2026, which replaced ISO 14155:2020 with no transition period. It sits at the clinical evidence stage of the device lifecycle. After design and verification, when a device needs human data to demonstrate clinical performance or safety, ISO 14155 governs how that data is generated.
Why ISO 14155 Matters in Medical Device Development
Clinical data drawn under ISO 14155 feeds directly into regulatory submissions. Under EU MDR 2017/745, higher-risk devices require clinical evidence to support conformity, and a clinical investigation conducted in accordance with GCP is the accepted means of producing it. The U.S. FDA recognizes ISO 14155 and accepts clinical data collected outside the United States when the study follows the standard.
The stakes are concrete. A study that deviates from GCP can be rejected by a notified body or the FDA, forcing a sponsor to repeat data collection at high cost and with delays. Poorly documented consent, weak ethics oversight, or untraceable source data also create audit exposure and, more seriously, put participants at risk. ISO 14155 exists to make that risk manageable and the resulting evidence defensible.
Key Requirements of ISO 14155
The standard structure of a clinical investigation is around a defined set of controls. The core elements include:
- A Clinical Investigation Plan (CIP) is the protocol that specifies objectives, design, endpoints, and statistical methods.
- An Investigator’s Brochure summarizing what is known about the device.
- Ethics committee or institutional review board approval before enrollment begins.
- Informed consent was obtained and documented for every subject.
- Risk management is integrated throughout the study and linked to, but distinct from, the device risk file under ISO 14971.
- Monitoring, including risk-based approaches, to confirm the study runs as planned and that data stays accurate.
- Adverse event and device deficiency recording, classification, and reporting.
- A Clinical Investigation Report (CIR) at close-out, plus registration of the study in a public database.
The 2026 edition raised the bar on several of these. It formalizes oversight bodies such as Clinical Events Committees (CECs) and Data Monitoring Committees (DMCs), introduces an estimand framework borrowed from pharmaceutical trials, tightens how missing data is planned for, and adds a structured adverse event tRisk management is now expected to focus on residual risks associated with the use of the investigational device, with risks from clinical procedures handled separately, in accordance with the principles of ISO 14971.SO 14971.
Common Challenges and Best Practices
The most frequent mistake is treating ISO 14155 as a documentation exercise rather than a study-design discipline. Teams that bolt the standard on at the end tend to discover gaps in consent records, source data, or monitoring trails during an audit, when they are expensive to fix.
A few patterns separate smooth investigations from troubled ones:
- Build the risk management link early so the CIP reflects the device’s specific residual risks rather than a generic template.
- Size the study for its population and indication instead of defaulting to a minimum.
- Define adverse event categories and causality assessment up front, since the 2026 taxonomy leaves less room for after-the-fact interpretation.
- Submit to the ethics committee with realistic timelines, and train every site on the protocol before the first subject is enrolled.
One regulatory subtlety deserves attention. In the EU, the version that provides presumption of conformity with the MDR has been the harmonized EN ISO 14155:2020 with its 2024 amendment, even though ISO has now published the 2026 edition. Before locking a protocol, sponsors should confirm which version their notified body expects.
Frequently Asked Questions
ISO 14155 is a voluntary consensus standard, not a law. In practice, it is treated as the expected method. EU MDR The EU MDR requires clinical evidence for many devices, and conducting investigations in accordance with ISO 14155 is the recognized route to satisfy this requirement. Accepts data generated under the standard. Regulators and notified bodies effectively expect compliance, so most sponsors follow it.
ISO 14155 governs the design and conduct of a clinical investigation of a medical device in accordance with Good Clinical Practice. Two connect: a study planned under ISO 14155 draws on the device risk file from ISO 14971, but the 2026 edition treats risks arising from clinical procedures as separate from device use risks.
The fourth edition, published in March 2026, replaced the 2020 version with no transition period. It formalizes Clinical Events Committees and Data Monitoring Committees, adds an estimand framework and stricter missing-data planning, introduces a structured adverse-event taxonomy, and sharpens the focus of risk management on residual risks associated with the investigational device. The shift is toward statistical rigor and proactive study design.
Yes. The FDA recognizes ISO 14155 and accepts clinical data collected outside the United States when the investigation was conducted in accordance with the standard. The standard aligns closely with ICH GCP principles, which support cross-jurisdiction acceptance. Sponsors planning U.S. submissions should still confirm any device-specific FDA expectations alongside ISO 14155 compliance.
Related Terms
- Clinical Evaluation Report (CER)
- Post-Market Clinical Follow-up (PMCF)
- ISO 14971
- EU MDR 2017/745
- Clinical Investigation Plan (CIP)
