The latest edition of ISO 14155 2026, the international Good Clinical Practice standard for medical device clinical investigations, has been published. ISO 14155:2026 replaces the 2020 version and introduces updated expectations across risk management, study oversight, clinical design, and safety reporting.

This is not a routine update. The changes affect how clinical investigations are planned, conducted, and documented, and they are already in effect. There is no defined transition period, so organisations must act now to ensure compliance. The timing is particularly significant. ISO 14155:2020 had only recently been harmonised under the EU MDR, so the 2026 update may require revisiting work that was only recently aligned with the previous standard. Delaying action could leave your studies and quality systems out of step with current expectations.

Key Changes in ISO 14155:2026

A More Structured Approach to Risk Management
The updated standard provides much greater clarity on managing risk in clinical investigations. It separates risks into distinct categories: those related to the investigational device and those arising from procedures outside routine clinical practice.

Device-related risks must be assessed with attention to the specifics of the investigation, including study population, intended use, and sample size. Adverse device effects observed during clinical investigations may differ from post-market experience, and this must be accounted for. For non-routine procedures, a descriptive assessment may be sufficient, but it still needs to be documented clearly.

For multi-country studies, what counts as routine clinical practice can vary between regions, so differences must be clearly identified in the clinical investigation plan. Organisations that fail to document these differences risk regulatory scrutiny.

Introduction of Clinical Events Committees
ISO 14155:2026 formally introduces Clinical Events Committees, which are independent groups of clinical experts established by the sponsor to ensure consistent classification and assessment of clinical events across study sites.

In multi-centre studies, similar events can be interpreted differently by investigators. A Clinical Events Committee reduces this variability and improves data reliability. Where a committee is used, its role, independence, and conflict-of-interest management must be clearly defined during study planning. 

Stronger Expectations for Data Monitoring Committees
Requirements for Data Monitoring Committees have been tightened. Where a committee is in place, sponsors must define clear criteria for when a study should be modified, paused, or stopped, and these criteria must be agreed in advance.

If a Data Monitoring Committee is not used, the decision must be justified and documented. These governance changes are no longer discretionary; they are mandatory expectations. 

Greater Emphasis on Study Design and Statistical Planning
ISO 14155:2026 places much more focus on study design and statistical planning. Guidance now aligns more closely with international approaches such as ICH E9(R1), including defining outcomes, handling missing data, and accounting for events in analysis.

For organisations working across both medical devices and pharmaceuticals, this alignment can streamline processes, but only if adopted promptly.

Expanded Expectations for Informed Consent and Subject Protection
Participant protection has been strengthened. Eligibility criteria, informed consent, personal data handling, and management of subject withdrawal are now under greater scrutiny.

We also see a strong focus on clarity of information for participants, particularly for vulnerable populations and cross-border studies. Consent documentation and processes must be reviewed to avoid compliance gaps.

A More Proportionate Approach to Adverse Event Reporting
The updated standard introduces a tailored approach to adverse event collection and reporting. Certain events may not need to be routinely collected or reported if justified within the clinical investigation plan. This is about structured oversight, not reducing accountability. 

What This Means for Your Organisation

Immediate Updates to Your Quality Management System
Procedures, templates, and SOPs that reference ISO 14155:2020 must be reviewed and updated without delay, particularly risk management processes and governance around Clinical Events Committees and Data Monitoring Committees.

We offer direct support to help you implement these changes quickly and confidently, including medical writing, documentation review, inspection readiness, internal process and SOP development, and ongoing quality system maintenance. You can find more details here: https://integrityclinicalcompliance.com/clinical-consultancy-services/

Assessing Ongoing Studies Urgently
For studies in early planning, the new requirements can usually be adopted immediately. For ongoing studies, we recommend carrying out a structured gap assessment to identify where updates are needed or where no change can be justified. All decisions must be clearly documented, as delays could lead to non-compliance.

Training Is Critical
Some changes, particularly in risk management and study design, are not obvious from the standard alone. Structured training for clinical, regulatory, and quality teams helps ensure consistent understanding and application.

We offer a range of online training courses, including a dedicated ISO 14155:2026 update course covering what has changed in this latest revision, as well as a comprehensive medical devices course currently being updated to reflect the new requirements. Explore our online clinical courses.

If you would like to be notified when new courses are released, you can register your interest here: https://integrityclinicalcompliance.com/contact/

Recommended Next Steps

We recommend starting with a focused gap analysis against ISO 14155 2026, paying particular attention to risk management, study design, and oversight structures. From there, update your quality management system, review ongoing and planned studies, and ensure that relevant teams receive training immediately.

Delaying these actions is not an option, as the standard is already in effect and compliance cannot be postponed. Monitoring progress around EU MDR harmonisation is also advised, as this will influence how the standard is applied in conformity assessments.

Take a look at our ISO 14155 2026 Course