Overview

Specifies good clinical practice for the design, conduct, recording and reporting of clinical investigations of medical devices in human subjects. The 2026 edition supersedes ISO 14155:2020.

ISO 14155:2026 specifies good clinical practice (GCP) for clinical investigations of medical devices involving human subjects. It is the current edition, published in 2026, superseding ISO 14155:2020. It covers the design, conduct, recording and reporting of investigations carried out to assess the clinical performance, effectiveness and safety of a medical device.

What it establishes. The standard has two intertwined objectives: protecting the rights, safety and well-being of human subjects, and ensuring that clinical investigations are scientifically sound so that the resulting clinical evidence is credible. It defines the responsibilities of sponsors and principal investigators, and it provides a common reference for ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices. It is the medical device counterpart to ICH GCP in the pharmaceutical world, and it is normatively referenced by device regulation in major markets.

Main changes in the current edition. The latest edition adds a summary section of GCP principles; references registration of the clinical investigation in a publicly accessible database; includes guidance on clinical quality management; reinforces risk management throughout the clinical investigation process; clarifies applicability to different clinical development stages; and adds guidance on clinical investigation audits.

Scope and boundaries. ISO 14155 can also be applied, where relevant, to post-market clinical follow-up investigations and to investigations involving Software as a Medical Device. It does not apply directly to in vitro diagnostic medical devices, although some of its requirements may be considered where national or regional rules permit — IVD clinical performance studies are addressed by ISO 20916.

What the standard covers in practice. Typical content includes ethical conduct and the requirements of the Declaration of Helsinki, informed consent, ethics committee review and approval, the clinical investigation plan and investigator's brochure, risk assessment and management for the investigation, selection and responsibilities of investigation sites and investigators, monitoring, data management and record keeping, handling of adverse events and device deficiencies including reporting timelines, statistical considerations, suspension and termination, and the clinical investigation report. Traceability of data and the ability to reconstruct the investigation from source records are recurring themes.

Related standards. ISO 14971 provides the risk management framework for medical devices, and clinical investigation risk assessment is expected to be consistent with it. ISO 13485 is the quality management system standard under which design and development, including clinical evidence generation, is controlled. ISO 20916 covers clinical performance studies for in vitro diagnostic devices, and ISO 20417 covers information supplied by the manufacturer.

Certification. ISO 14155 is a requirements standard for the conduct of investigations, not a management system standard, and there is no organizational certification against it. Conformity is demonstrated through the clinical investigation documentation and is assessed by ethics committees, regulatory authorities, notified bodies and sponsor or third-party audits.

Purpose

To define good clinical practice for clinical investigations of medical devices in human subjects, protecting subject rights, safety and well-being while ensuring investigations are scientifically sound and produce credible clinical evidence.

Key Benefits

• Current 2026 edition superseding ISO 14155:2020
• Internationally recognized GCP reference for medical device investigations
• Clear allocation of sponsor and principal investigator responsibilities
• Common reference point for ethics committees, regulators and notified bodies
• Applicable to pre-market and post-market clinical follow-up investigations
• Explicitly addresses Software as a Medical Device investigations
• New guidance on clinical quality management and clinical investigation audits

Key Requirements

• Conduct investigations in accordance with ethical principles and applicable regulation
• Obtain ethics committee review and approval before starting
• Obtain and document informed consent from subjects
• Register the clinical investigation in a publicly accessible database
• Prepare a clinical investigation plan and investigator's brochure
• Apply risk management throughout the investigation
• Define sponsor and principal investigator responsibilities
• Select and qualify investigation sites and investigators
• Monitor the investigation and maintain traceable source data and records
• Record, assess and report adverse events and device deficiencies within required timelines
• Apply clinical quality management and conduct audits as appropriate
• Manage suspension, termination and close-out
• Produce a clinical investigation report

Who Needs This Standard?

Medical device manufacturers acting as sponsors, clinical research organizations running device studies, principal investigators and clinical sites, ethics committees and institutional review boards, regulatory affairs and clinical affairs teams, notified bodies and regulators assessing clinical evidence.

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