The fourth edition of ISO 14155 was published on March 23, 2026, and replaces the 2020 version
- Date
- April 14, 2026
- Category
Other Regulations
- Description
The International Organization for Standardization officially published the fourth edition of ISO 14155, the global standard for Good Clinical Practice in clinical investigations of medical devices.
The revised standard primarily focuses on clarifying existing requirements and aligning expectations more closely with a risk‑based and proportionate approach. One important clarification concerns the distinction between residual risks related to the use of the device and risks related to clinical procedures which are not part of routine clinical practice. The standard now clearly emphasizes that management of the risks related to the clinical procedures and investigation processes differs from the principles outlined in ISO 14971. Additional guidance has been introduced to support sponsors in addressing these aspects in a structured and consistent way.
Overall, the ISO 14155:2026 largely builds on established principles, but introduces several targeted enhancements to strengthen study oversight, data integrity, and subject safety. Sponsors are now expected to justify the absence of a Data Monitoring Committee (DMC), reinforcing transparency and a risk‑based approach to safety monitoring. Furthermore, a dedicated section on Clinical Events Committees (CECs) is introduced. Sponsors shall consider establishing a CEC to reinforce safety oversight while reducing variability and potential bias in data interpretation. Finally, a new informative annex, Annex K, was added addressing considerations for clinical investigation design.
For sponsors and medical device manufacturers, this means that existing clinical strategies, templates, and processes should be reviewed and, where necessary, updated to reflect the clarified expectations, especially regarding risk management, study oversight, and documentation.
How we support you
We support medical device manufacturers in implementing ISO 14155:2026 through targeted gap analyses and tailored consulting services, helping to efficiently align clinical investigation processes with the updated requirements. We are happy to assist you in navigating the transition to ISO 14155:2026 with confidence.