ISO 14155:2026— Clinical Investigation of Medical Devices

Bringing a medical device to market is not just about innovation; it is about trust. Before a device ever reaches a patient, it must undergo rigorous clinical evaluation to prove it is safe and performs as intended. ISO 14155:2026— Clinical investigation of medical devices for human subjects – Good clinical practice sets the benchmark for good clinical practice (GCP) in medical device investigations involving human subjects, assuring that studies are ethical, scientifically sound, and globally credible.

Clinical Investigation of Medical Devices Explained

Clinical investigation of medical devices involves systematic, human-subject studies to assess safety and performance, which are crucial for regulatory approval (e.g., FDA, EU MDR). These studies are governed by standards like ISO 14155:2026 to assure ethical, high-quality data, particularly for high-risk, new, or modified devices.

What Is ISO 14155:2026?

ISO 14155:2026 specifies good clinical practice (GCP) for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices. This document specifies the general requirements intended to:

• Protect the rights, safety and well-being of human subjects, users, or other persons
• Assure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results
• Define the responsibilities of the sponsor and principal investigator
• Assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

ISO 14155:2026 does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, where users of this document can consider whether either specific sections or requirements of this document, or both, can be applicable.

What Is Good Clinical Practice (GCP)? – A Foundation for Ethical Clinical Research

Good clinical practice (GCP) is a globally recognized framework that defines how clinical trials involving human subjects should be designed, conducted, and reported to ensure both participant safety and data integrity. GCP serves as an ethical and scientific quality standard that protects the rights and well-being of participants while ensuring that clinical data is credible and reliable.

In the medical device space, GCP principles are operationalized through standards like ISO 14155:2026, which provide detailed guidance on study protocols, documentation, monitoring, and auditing. Today, adherence to GCP is essential for regulatory acceptance worldwide, helping streamline approvals, reduce delays, and assure that clinical investigations meet increasingly stringent global expectations.

What Are the Changes in the 2026 Edition of ISO 14155?

ISO 14155:2026 replaces the 2020 version and introduces a more structured and rigorous approach to clinical investigations. The standard strengthens risk management by clearly distinguishing between device-related risks and those from non-routine procedures, while requiring better documentation, especially in multi-country studies where clinical practices vary. It also formalizes the role of Clinical Events Committees to improve consistency in event classification and reinforces stricter expectations for Data Monitoring Committees, including predefined criteria for modifying or stopping studies.

In addition, there is a stronger focus on study design and statistical planning, aligning more closely with global frameworks, alongside expanded requirements for informed consent and participant protection. Finally, the standard adopts a more proportionate, risk-based approach to adverse event reporting, allowing flexibility while maintaining accountability and data integrity.

Where to Find ISO 14155:2026

ISO 14155:2026 is an essential standard in healthcare, where patient safety and outcomes are directly at stake. By establishing clear expectations for ethical conduct, risk management, and data integrity, this international standard assures that medical device trials are not only effective but also reliable and trustworthy.

ISO 14155:2026— Clinical investigation of medical devices for human subjects – Good clinical practice is available on the ANSI Webstore.