Is ISO 14155 mandatory for all clinical investigations?

While not always explicitly mandated by law in every jurisdiction, regulatory bodies like the FDA and those operating under the EU MDR expect adherence to ISO 14155 principles for clinical investigations intended to support regulatory submissions. It is considered the international standard for good clinical practice for devices.

What is the role of a sponsor in an ISO 14155 compliant study?

The sponsor is responsible for initiating, managing, and financing the clinical investigation, ensuring it is conducted in accordance with ISO 14155, applicable regulations, and the investigational plan. This includes selecting qualified investigators and ensuring appropriate oversight.

Does ISO 14155 apply to post-market clinical follow-up (PMCF) studies?

Yes, the principles of ISO 14155 are generally applicable to PMCF studies, especially when these studies involve collecting new clinical data from human subjects to address specific questions about a device's safety or performance in its post-market phase.

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StandardsQuality System Clinical Evidence

ISO 14155

Good clinical practice for clinical investigations of medical devices.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed September 19, 2026

Definition

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.

What the regulation says

ISO 14155:2020 outlines the principles of good clinical practice (GCP) for medical device clinical investigations, ensuring the protection of human subjects, the scientific integrity of the investigation, and the reliability of study results. The EU MDR, specifically in Annex XV, refers to the principles of ISO 14155 for clinical investigations of devices.

What this means in practice

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

Examples

A MedTech company conducting a clinical investigation for a novel coronary stent needs to ensure all study procedures, from subject consent to data collection, are compliant with ISO 14155:2020.
Before initiating a multi-center clinical trial for a new diagnostic imaging device, the sponsor performs site audits to verify that each participating institution understands and can adhere to ISO 14155 requirements.
During a clinical investigation for a new orthopedic implant, a data monitoring committee operating under ISO 14155 principles reviews accumulating data to ensure subject safety and ethical conduct.

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.

Frequently asked questions

ISO 14155 is specifically tailored for medical devices, addressing their unique characteristics like device-specific risks and iterative design, while ICH-GCP is focused on pharmaceuticals. Both share core principles of ethical conduct and data integrity.

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Good clinical practice for clinical investigations of medical devices.

·ISO 14155 is the device-specific counterpart to ICH-GCP and is referenced by EU MDR clinical investigation requirements.
·The 2020 edition added risk-based monitoring, registration of investigations in public databases and guidance on post-market clinical studies.

Remember this

Watch out: Failing to update clinical investigation procedures to align with the 2020 revision of ISO 14155 can lead to non-compliance.

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