ISO 14155:2026 – What’s New and Why It Matters for Medical Device Clinical Investigations

Overview

The International Organization for Standardization (ISO) has released ISO 14155:2026, the fourth edition of the international standard governing Good Clinical Practice (GCP) for clinical investigations of medical devices in human subjects. This new edition replaces ISO 14155:2020 and reflects a continued effort to strengthen participant protections, clarify responsibilities, and modernize expectations for the design and conduct of device clinical investigations.

For investigators, sponsors, ethics committees, and research institutions, understanding the changes in ISO 14155:2026 is essential. The revised standard introduces new concepts, refines existing requirements, and provides greater clarity in areas that have historically generated confusion during study planning, conduct, and oversight. This blog highlights several of the most important updates and discusses their practical relevance for the clinical research community.

Clarifying “Clinical Performance” and Study Purpose

ISO 14155:2026 refines the definition of clinical performance, making clear that performance relates to a medical device’s ability to achieve its intended purpose and lead to clinical benefit when used as intended by the manufacturer. At the same time, the revised definition explicitly acknowledges that not all clinical investigations provide direct benefit to study participants, such as studies involving healthy volunteers or investigations designed primarily to collect clinical data.

This clarification supports more transparent communication with ethics committees and study participants and reinforces the importance of aligning study objectives with appropriate risk–benefit considerations.

A More Structured Approach to Risk Management

Risk management remains a central theme in ISO 14155:2026, but the revised standard takes a more structured and explicit approach. One of the most notable changes is a clear distinction between:

• Risks related to the use of the investigational medical device; and
• Risks associated with clinical procedures required by the clinical investigation plan (CIP) that fall outside routine clinical practice.

Sponsors are now expected to assess and document these categories of risk separately. The revised standard also introduces stronger expectations around the evaluation of residual risks related to device use and requires greater consistency in how risks are described across study documentation, including the CIP, investigator’s brochure, and informed consent materials.

This clearer framework is intended to support more meaningful risk assessments and improve participant understanding of potential harms.

Expanded Guidance on Risk Management During Study Conduct

ISO 14155:2026 places greater emphasis on ongoing risk management throughout the lifecycle of a clinical investigation, not just during study planning. New and revised sections describe how sponsors and investigators should evaluate emerging safety information, determine when risks may become unacceptable, and take appropriate action, including suspending enrollment or amending the protocol when necessary.

Importantly, the revised standard distinguishes between managing risks related to device use and managing risks arising from non‑routine clinical procedures specified in the CIP. This added clarity is particularly relevant for complex studies and post‑market investigations, where procedures may vary from standard clinical practice.

Introduction of Clinical Events Committees

A significant structural addition in ISO 14155:2026 is the introduction of Clinical Events Committees (CECs). CECs may be established to ensure consistent classification and adjudication of safety or effectiveness endpoints across sites, particularly in multicenter studies.

While not required for every investigation, the inclusion of CECs reflects a growing emphasis on data consistency and interpretability. When sponsors choose to establish a CEC, the standard outlines expectations for committee responsibilities, independence, and documentation through a formal charter.

Strengthened Expectations for Data Monitoring Committees

Data Monitoring Committees (DMCs) continue to play a key role in participant safety oversight. ISO 14155:2026 strengthens this role by requiring that DMC charters clearly define conditions under which a study may be modified, suspended, or stopped for safety reasons.

For investigations in which no DMC is established, sponsors must now justify this decision in the CIP. This change reinforces a risk‑based approach to safety oversight and encourages thoughtful consideration of whether independent monitoring is appropriate, given a study’s design and risk profile.

Updates to Informed Consent Practices

Several revisions in ISO 14155:2026 reinforce informed consent as an ongoing, participant‑centered process. Key clarifications include:

• Explicit recognition that informed consent must be obtained from a legally designated representative when applicable.
• A new requirement that potential participants be given adequate opportunity to discuss study participation with others, such as family members, if they choose.
• Additional transparency around continued care, data use, and participation following withdrawal.

These updates align ISO 14155 more closely with international ethical principles and contemporary expectations for respect for persons.

Clearer Rules for Eligibility Criteria and Protocol Deviations

ISO 14155:2026 clarifies that deviations from eligibility criteria are not permitted. Any changes to eligibility requirements must be handled through a formal amendment to the CIP, reviewed and approved by the appropriate oversight bodies.

This clarification addresses a common area of misunderstanding and underscores the importance of protocol adherence, investigator training, and proactive communication with sponsors and ethics committees.

More Detailed Expectations for Clinical Investigation Plans

Many requirements that previously appeared only in annexes are now embedded directly in the core text of ISO 14155:2026. The revised standard places greater emphasis on the contents and structure of the CIP, including clearer requirements related to study objectives, endpoint specification, and data analysis considerations.

Implications for Sponsors, Investigators, and Institutions

ISO 14155:2026 does not radically change the foundations of GCP for medical device investigations. Instead, it clarifies expectations, strengthens oversight mechanisms, and responds to lessons learned from the application of earlier editions.

For investigators and study teams, these changes highlight the importance of training, documentation, and proactive risk management. For sponsors and institutions, the revised standard reinforces accountability across the full lifecycle of a clinical investigation.

Moving Forward

As ISO 14155:2026 is increasingly referenced by regulators and ethics committees worldwide, familiarity with its updates will be essential. Education and training play a critical role in supporting compliance, protecting research participants, and promoting high‑quality clinical investigations.

CITI Program has fully updated its GCP device courses and other content that references ISO 14155. We remain committed to helping the research community understand evolving international standards and their implications for ethical and regulatory practice.