ISO 14155:2026 Changes

Introduction to ISO 14155

The International Organization for Standardization (ISO) develops independent, international standards in various sectors with the mission to “make lives easier, safer and better”. In healthcare, the ISO standards aim to enhance patient safety and foster innovation in sustainable solutions. The standard that applies to medical device clinical studies is ISO 14155 “Clinical investigation of medical devices for human subjects — Good clinical practice”. This document harmonizes with the International Conference on Harmonisation Guideline on Good Clinical Practice (GCP) E6(R2). The fourth edition of ISO 14155 was published in March 2026, replacing the 2020 version. While most of the text remains the same, clarifications and additions were included that center around risk management, data oversight groups, adverse event reporting, and ensuring patient rights, safety, and welfare.

Risk Management

Although residual risk was mentioned in the previous version, the requirements were focused on informing the risk to the investigators and patients. Now in the 2026 version, an assessment of residual risk is required.

In addition to the risks associated with use of the device, ISO 14155:2026 includes separate sections about the consideration of risks associated with clinical procedures required by the protocol outside of routine clinical practice. These risks should be identified and disclosed in the protocol and informed consent along with the risks associated with the device under investigation.

Data Oversight Groups

A data monitoring committee (DMC) provides independent oversight of safety and efficacy data from an on-going clinical study. Confirming conditions for suspending or stopping the clinical investigation were added as an activity for the DMC. This has already been a task of the data monitoring committee in practice, but now is explicit in the 2026 update.

A section about establishing an independent clinical events committee (CEC) has been added. In the new definition for CEC, their mission is described as “to ensure consistent event assessment across participating centres and mitigate inadequate reporting risks”. This is an important distinction from a DMC since a DMC usually assesses aggregated data for trends whereas the CEC is focused on specific events and endpoints.

The 2026 update added the requirement to include information about these committees in the protocol. If these committees are not established, then a justification should be provided.

Adverse Event Reporting

Every study is unique so the adverse event reporting plan should be too. For example, a study may only require reporting of laboratory values out of range if they are considered clinically significant or have associated symptoms. Reduced recording and reporting can ease the burden on the site and Sponsor. The 2026 update adds a clarification that reduced recording or reporting of adverse events is appropriate as long as exceptions are identified and justified in the protocol and approved by the institutional review board and/or regulatory authority.

Another addition to adverse event reporting requirements is the recommendation for standardized terminology to code adverse events. To have consistent reporting within and across studies, Sponsors often use common dictionaries like Medical Dictionary for Regulatory Activities (MedDRA), Common Terminology Criteria for Adverse Events (CTCAE), or the International Medical Device Regulators Forum (IMDRF) Terminologies for Categorized Adverse Event Reporting.

The classification of adverse events has also been updated to differentiate between device-related and study-related adverse events. “Procedure-related” events have been interpreted to be related to procedures involving the investigational device such as implantation. ISO 14155:2026 introduces a new category of “protocol-required procedures outside of routine clinical practice” that are not related to device use. An example of “protocol-required procedure outside of routine clinical practice” is frequent follow-up contrast imaging to monitor device integrity. If a patient develops contrast-induced nephropathy, then the event would be related to the follow-up procedure, not the device itself. The patient would not have experienced the event if he or she was not involved in the study.

Patient Rights, Safety, and Welfare

In the 2026 version, a clarification was added to the section on the informed consent process. Previously, the process should include providing the patient with ample time to read and understand their participation. A clarification was added to specify that the patient should also have time to ask questions and discuss with others (e.g., family). Answering patient questions is also included in ICH GCP.

For implantable devices, an implant card must be provided to the patient that includes device identification, manufacturer details, and safety information (e.g., MRI compatibility). Although a requirement under European Union Medical Device Regulations, implant cards were previously not mentioned in ISO 14155 until the 2026 update.

Is your study ready for ISO 14155:2026? We can help!

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