ISO 14155:2026 (published March 2026) is the updated international standard for Good Clinical Practice (GCP) in clinical investigations of medical devices in human subjects.
What’s new (selected changes)
- Updated definition of clinical performance
- Clarified handling of eligibility criteria deviations and related CIP amendments
- Strengthened detail around informed consent (including legally designated representatives where applicable, and opportunity to consult others)
- More explicit risk management expectations (separating risks from device use vs. risks from non-routine clinical procedures; assessing residual risks)
- Expanded expectations for oversight and governance (e.g., data monitoring committee related conditions for suspension/stop; new clinical events committee section)
- Clarifications related to adverse event reporting, statistical considerations (e.g., non-inferiority margins, missing data), estimands, and inclusion of in-silico tests in relevant contexts
Practical implication
Teams running or preparing device investigations may want to review whether their CIP/protocol structure, risk documentation, committee charters (data monitoring committee / clinical events committee), and reporting procedures reflect the updated expectations.