ISO 14155:2020

ISO 14155:2020 specifies the requirements for the design, conduct, recording, and reporting of clinical investigations carried out to assess the safety and performance of medical devices in human subjects. It establishes good clinical practice (GCP) principles specific to medical device investigations, ensuring subject protection and data integrity.

Overview

Background

Published by the International Organization for Standardization (ISO), this standard was developed to provide an internationally harmonized approach to clinical investigation of medical devices. The 2020 edition incorporated lessons learned from clinical practice and aligned with evolving regulatory requirements, including those of the EU MDR and IVDR which explicitly reference this standard.

Applicability

This standard applies to sponsors, monitors, investigators, ethics committees, and regulatory authorities involved in clinical investigations of medical devices. It covers investigations conducted to support regulatory submissions, post-market clinical follow-up (PMCF), and performance studies for IVD devices. It is recognized globally as the benchmark for medical device clinical investigation quality.

Core Principles

Ethical principles and subject protection

Clinical investigation planning and protocol design

Informed consent requirements

Risk-based monitoring approach

Data management and statistical analysis

Adverse event recording and reporting

Sponsor and investigator responsibilities

Clinical investigation reporting