Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans

This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimising the scientific validity and reproducibility of the results of a clinical investigation.

This Standard does not apply to in vitro diagnostic medical devices.