SIST EN ISO 14155:2026 specifies good clinical practice for clinical investigations of medical devices involving human subjects. It provides requirements for planning, conducting, recording, and reporting investigations intended to assess the clinical performance, effectiveness, and safety of investigational medical devices.
The standard addresses sponsor and investigator responsibilities, subject protection, ethics, informed consent, clinical investigation plans, risk management, safety reporting, data handling, monitoring, audits, and clinical investigation reporting. It supports pre-market and post-market investigations and includes informative guidance on clinical development stages, audit practices, and clinical investigation design considerations.
Application Scope: Applicable to medical device manufacturers, clinical research organizations, sponsors, investigators, ethics committees, and regulatory professionals conducting or overseeing clinical investigations of medical devices in human subjects.
