02/04/2025
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The International Organization of Standardization (ISO) is a non-governmental federation comprised of 173 national standard bodies dedicated to creating and maintaining up to date International Standards. Each field has a technical committee (TC) responsible for creating, reviewing, and updating ISOs on a routine basis, typically every five years. The International Standard ISO 14155 “Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice” outlines what is considered good clinical practice for the design, conduct, recording, and reporting of clinical investigations of medical devices in human participants.
As we enter 2025, a Draft International Standard (DIS) of ISO 14155 is in the final stages of the approval process and is expected to be released within the coming months to replace the existing ISO (please see our previous blog entry for more information on the changes brought on by ISO 14155:2020). Technical revisions and changes to the previous edition include:
Change in the definition of clinical performance
2020: behavior of a medical device and response of the subject(s) to that medical device in relation to its intended use, when correctly applied to appropriate subject(s)
2025: ability of a medical device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for subject(s), when used as intended by the manufacturer
Clarifications on the trial participant’s rights
Informed consent to be obtained where applicable from subject’s legally designated representative
Subject must be given opportunity to discuss participation with others e.g. family members
New requirements for Data Monitoring Committees (DMC)
DMC to confirm conditions for suspending or stopping the clinical investigation
Requirement to justify absence of DMC involvement.
A full list of significant changes is provided in the ISO/DIS14155 along with the first 3 sections of the DIS for free, the entire document is also available for purchase. If you or your business would like more formal training on these standards as well as the changes that will be implemented, Clinical Pathways offers a wide variety of consulting services and training to help make sure you and your company meet these standards.
The Clinical Pathways Team
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