ISO 14155:2026 replaced the 2020 edition in March 2026. The new edition introduces a two-track approach to risk management, a formal clinical events committee, tighter rules around informed consent and eligibility deviations, and a first-time framework for statistical estimands. Teams still working from 2020-edition templates and procedures have real gaps to close before their next study.

Inside this guide:

• How sponsor and principal investigator responsibilities divide under Clauses 9 and 10, and what stays with the sponsor even when work is outsourced to a CRO
• What belongs in a compliant clinical investigation plan (CIP), investigator's brochure (IB), and case report forms (CRFs) under the fourth edition
• How the new risk management structure separates device-use risk from risk tied to non-routine clinical procedures
• How adverse events and device deficiencies get categorized and reported, including the new device-deficiency pathway in Annex F
• What the estimand framework in the standard's new Annex K means for statistical design
• What ISO 14155:2026 requires of electronic data capture systems, and how to evaluate whether your current EDC meets it