ISO 14155:2026

Overview

ISO 14155:2026 sets the international standard for Good Clinical Practice (GCP) in clinical investigations involving medical devices used with human subjects. Developed by ISO, this essential guideline outlines requirements for the design, conduct, documentation, and reporting of clinical studies that assess the safety and performance of medical devices. The standard is applicable throughout various stages of medical device development, including pre-market and post-market clinical investigations. Its primary aim is to protect human subjects, ensure credible scientific results, and establish the responsibilities of sponsors, investigators, ethics committees, and regulatory authorities involved in medical device assessment.

Key Topics

ISO 14155:2026 covers comprehensive topics critical to the ethical and scientific integrity of medical device clinical trials, including:

• Ethical Considerations: Details requirements to safeguard the rights, safety, and well-being of participants, including informed consent, assessment for vulnerable populations, and communication with ethics committees.
• Clinical Investigation Planning: Outlines the creation of the Clinical Investigation Plan (CIP), risk management strategies, investigator’s brochure, site selection, data management, and monitoring plans.
• Conduct of Investigations: Specifies procedures for site initiation and monitoring, managing adverse events and device deficiencies, ensuring subject privacy, and maintaining data integrity.
• Reporting and Documentation: Defines processes for amendments, audit trails, clinical investigation reports, and data retention to support transparency and regulatory review.
• Sponsor and Investigator Responsibilities: Clarifies duties related to clinical quality management, personnel training, communication with regulatory bodies, compliance with protocols, and safety reporting.
• Risk Management: Reinforces assessment and management of risks associated with devices and clinical procedures, in alignment with ISO 14971.
• Software as a Medical Device (SaMD): Provides principles for demonstrating analytical validity, scientific validity, and clinical performance for SaMD, stressing careful consideration due to indirect patient contact.

Applications

ISO 14155:2026 delivers practical guidance for organizations involved in the clinical development and assessment of medical devices, including:

• Manufacturers: Establish robust clinical investigation processes to demonstrate regulatory compliance and marketplace safety evidence for medical devices.
• Clinical Research Organizations (CROs): Ensure adherence to GCP in trial management, from protocol development through data analysis and reporting.
• Ethics Committees and Institutional Review Boards: Evaluate study protocols to confirm participant safety, informed consent, and ethical trial conduct.
• Regulatory Authorities: Assess clinical trial data against internationally harmonized criteria, facilitating device approvals and market surveillance.
• Researchers and Investigators: Plan, initiate, and document clinical investigations while meeting regulatory and ethical obligations.
• Post-Market Surveillance: Apply relevant GCP principles to ongoing studies after device commercialization, supporting continuous evaluation of safety and performance.

Related Standards

ISO 14155:2026 is closely aligned with other regulatory and quality management standards, including:

• ISO 14971 – Application of Risk Management to Medical Devices: Integrates risk management requirements throughout clinical investigation planning and execution.
• Good Clinical Practice (ICH-GCP, E6): Shares foundational GCP principles but is specifically tailored for medical devices rather than pharmaceuticals.
• Regional and National Medical Device Regulations: Complements requirements set by regulatory agencies in the EU, US (FDA), and other regions.

While ISO 14155:2026 does not apply to in vitro diagnostic devices, some requirements may be relevant depending on device type and regional mandates. Additionally, users should always consider the most stringent applicable regulatory or standard requirements during clinical investigation planning.

By implementing ISO 14155:2026, organizations can ensure ethical, scientifically sound clinical trials, protect human subjects, and support global harmonization in medical device evaluation. This standard facilitates the market authorization process and continuous post-market safety monitoring-making it a critical resource for all stakeholders in the medical device sector.