ISO 14155-2020 PDF

Full title and description

ISO 14155:2020 — Clinical investigation of medical devices for human subjects — Good clinical practice. This international standard specifies good clinical practice (GCP) requirements for the design, conduct, recording and reporting of clinical investigations involving human subjects to assess clinical performance, effectiveness and safety of medical devices.

Abstract

ISO 14155:2020 sets out principles and requirements intended to protect the rights, safety and well‑being of trial subjects, to ensure scientific conduct and credibility of clinical investigation results, to define responsibilities of sponsors and principal investigators, and to assist ethics committees, regulatory authorities and other bodies involved in device conformity assessment. It covers pre‑market and, where relevant, post‑market clinical investigations and includes considerations for software as a medical device (SaMD) and modern risk‑based approaches.

General information

• Status: Published.
• Publication date: July 2020 (third edition).
• Publisher: International Organization for Standardization (ISO), developed by ISO/TC 194.
• ICS / categories: 11.100.20 (Biological evaluation of medical devices).
• Edition / version: Edition 3 — ISO 14155:2020.
• Number of pages: 83 pages.

Scope

Applies to clinical investigations of medical devices conducted with human subjects to assess safety and clinical performance or effectiveness. The standard does not apply to in vitro diagnostic medical devices in general, though certain sections may be considered where relevant; it is intended to be followed for both pre‑market and, as applicable, post‑market investigations with adaptation for the nature of the investigation.

Key topics and requirements

• Thirteen GCP principles forming the ethical and scientific foundation for device clinical investigations (subject protection, scientific validity, qualified personnel, risk‑based approach, etc.).
• Requirements for sponsor and principal investigator responsibilities, delegation, training and oversight.
• Protocol and clinical investigation plan content, amendment handling and justification.
• Informed consent, ethics committee review and subject information requirements (including e‑consent considerations where applicable).
• Risk management integrated throughout the investigation, alignment with device risk management principles (e.g., ISO 14971).
• Monitoring, data management, data integrity (ALCOA+/documentation), and statistical considerations.
• Serious adverse event (SAE) reporting, vigilance requirements and safety follow‑up processes.
• Clinical investigation registration and transparency (register before first subject enrollment and obligations around results posting).
• Special considerations for Software as a Medical Device (SaMD), iterative device changes, operator learning curves and post‑market clinical follow‑up (PMCF).

Typical use and users

Primary users are medical device manufacturers (sponsors), clinical investigators and study sites, contract research organizations (CROs), ethics committees/IRBs, regulatory authorities and notified bodies, and organizations conducting post‑market clinical follow‑up. Clinical quality assurance, regulatory affairs and clinical operations professionals rely on ISO 14155:2020 when planning and executing device clinical investigations intended for regulatory submissions or PMCF programs.

Related standards

Commonly referenced and related documents include ISO 14971 (risk management for medical devices), ICH E6 (Good Clinical Practice) for comparison of GCP principles, relevant national/regional regulations such as EU Medical Device Regulation (EU MDR 2017/745) and applicable FDA guidance (including IDE/21 CFR considerations). ISO 14155:2020 is intended to harmonize with these frameworks where appropriate.

Keywords

ISO 14155, clinical investigation, medical device, GCP, good clinical practice, sponsor, principal investigator, informed consent, risk‑based monitoring, SaMD, post‑market clinical follow‑up, ISO 14971, EU MDR.

FAQ

Q: What is this standard?

A: ISO 14155:2020 is the international Good Clinical Practice standard for clinical investigations of medical devices involving human subjects, providing ethical and scientific requirements for study conduct.

Q: What does it cover?

A: It covers design, conduct, recording and reporting of clinical investigations for medical devices, including sponsor and investigator responsibilities, protocol content, informed consent, monitoring, data integrity, safety reporting, and transparency measures such as trial registration and results posting.

Q: Who typically uses it?

A: Manufacturers/sponsors, principal investigators and site staff, CROs, ethics committees/IRBs, notified bodies and regulatory authorities, and clinical quality/regulatory professionals use this standard during the planning and execution of device clinical investigations.

Q: Is it current or superseded?

A: ISO 14155:2020 (third edition) is the published standard from July 2020. Users should check for any amendments or newer editions before relying on the text for regulatory submissions, as revisions or replacements may be released; the ISO catalogue notes the standard is subject to periodic review.

Q: Is it part of a series?

A: ISO 14155 is a standalone GCP standard for medical device clinical investigations but is typically used alongside device standards and regulatory requirements (for example ISO 14971 for risk management and relevant regional regulations such as EU MDR and national guidance).

Q: What are the key keywords?

A: Key keywords include clinical investigation, medical device, GCP, sponsor, principal investigator, informed consent, risk management, data integrity, SaMD, PMCF, ISO 14971, EU MDR.