Update - ISO 14155 Device GCP 2026 and Clinical Pathway’s New eLearning & Comparison Tool

06/07/2026

Photo by Navy Medicine on Unsplash

In March 2026, the International Organization for Standardization (ISO) published the fourth edition of ISO 14155:2026 Clinical investigation of medical devices for human subjects — Good clinical practice (GCP), replacing the previous edition from 2020. This is the medical device global reference for GCP conduct that many regulatory authorities recognize, like ICH Harmonized Guideline for Good Clinical Practice E6(R3) for drugs and biologics. The purpose of this document is to set the standards for designing, conducting, recording and reporting clinical investigations carried out in human participants that assess the effectiveness and safety of medical devices ensuring participants’ rights, safety and wellbeing as well as data integrity and reliability are protected.

This new edition was published after ICH E6(R3), which was finalized in January of 2025. In both documents, the GCP principles are derived from the Declaration of Helsinki (DoH). In ISO 14155, the GCP principles are condensed into 13 overarching principles whereas E6(R3) uses 11 with expanded explanatory subprinciples. Like in E6(R3), the roles, responsibilities, and considerations for trial’s Ethics Committee (EC), Sponsor, and Principal Investigator have their own sections in ISO14155, however, ISO14155 has additional sections dedicated to ethical considerations, clinical investigation planning and conduct, and suspension, termination, and close-out of clinical investigations for medical devices.

In comparison to the 2020 edition, ISO14155:2026 retains the same overall structure and sections of 2020 with addition of a brief introductory paragraph. The differences between the editions are outlined in the Forward which lists the main changes, additions, updates, and clarifications within the standard. Notable additions include:

  • A requirement for data monitoring committees (DMC) to confirm conditions for suspending or stopping the clinical investigation (see 6.11): these conditions are to be documented in the DMC charter during the planning phase of the study.

  • A new section and definition on clinical events committee (CEC) (see 3.8, 6.12 and Clause A.14): CEC is defined in the “Terms and Definitions” as an “independent committee of clinical experts that can be established by the sponsor to ensure consistent event assessment across participating centers and mitigate inadequate reporting risks”. While using a CEC is not required, it is recommended that sponsors consider establishing one and develop a CEC charter, like that of a DMC, that documents:

    • methods for central review and classification of safety or effectiveness endpoints,

    • criteria for determining whether potential endpoints meet Clinical Investigation Plan (CIP) definition of endpoints,

    • methods for standardized endpoint outcomes for statistical analysis,

    • and classifications of events (including serious adverse device effects and device deficiencies) as related to the use of the investigational device or the clinical procedures required by the CIP and their anticipatedness.

  • New requirements (previously in Annex A) to 6.4: Annex A “Clinical Investigation Plan” 6.4 “Procedures” now includes 2 additional points:

    • Methods and timing for assessing, recording and analyzing variables.

    • Equipment to be used for assessing the clinical investigation variables and arrangements for monitoring maintenance and calibration.

As a reminder, the ISO Standards are not free for download, like ICH Guidelines. ISO 14155:2026 is currently available for license purchase at https://www.iso.org/standard/83968.html. Trying to navigate and understand the nuances of this 94-page standard can be a difficult and tedious task, which is why Clinical Pathways has an established eLearning for ISO 14155, and is updating the training to the 2026 version requirements. The target date for the release is June 15th, 2026. Limited presales for 10% off list price are available by entering the code GCP2026 during checkout here.

Clinical Pathways offers an ISO14155 Comparison Tool which can be purchased now. This will support you to do an impact analysis and plan updates to SOPs, templates and tools for your trials. If you or your company are interested in this tool, please visit our online store.

While you’re there, have a look through our course catalog to see if any of our other services may be of interest to you, and subscribe to our free newsletter and blog to keep up to date on clinical trial related news such as this.  

-The Clinical Pathways Team

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