The new version of ISO14155 arrived! |
23rd of March 2026 ISO published the new version of ISO 14155. Changes include
- A changed definition of clinical performance;
- Clarification that deviations from eligibility criteria are not allowed and subject to CIP amendment;
- Clarifications concerning informed consent;
- Clarification regarding risk management and residual risks;
- Added requirements with respect to the CIP;
- Added requirements for the Data Monitoring and clinical events committee;
- Clarified situations of reduced adverse events reporting requirements, updated adverse events categorization, and addition of adverse events associated with a device deficiency.
In other words all involved in medical device clinical trials regardless whether pre-market or post-market, interventional or observational should take note of it.
https://www.iso.org/standard/83968.html
