ISO 14155:2020

Overview - ISO 14155:2020 (Good Clinical Practice for Medical Devices)

ISO 14155:2020 specifies Good Clinical Practice (GCP) for the design, conduct, recording and reporting of clinical investigations in human subjects to evaluate the clinical performance, effectiveness and safety of medical devices. The standard defines general requirements to protect subject rights and safety, ensure scientific integrity and credibility of results, and clarify the responsibilities of sponsors and principal investigators. It applies to pre‑market and, as relevant, post‑market clinical investigations; it excludes in vitro diagnostics but includes applicability guidance for Software as a Medical Device (SaMD).

Key topics and technical requirements

• Ethical considerations and informed consent - protecting vulnerable populations, avoiding undue influence, and documenting consent processes.
• Clinical investigation planning - risk evaluation/management, justification of design, Clinical Investigation Plan (CIP), Investigator’s Brochure (IB) and Case Report Forms (CRFs).
• Monitoring and oversight - monitoring plans, site initiation, site monitoring, Data Monitoring Committees (DMC) where applicable.
• Safety and device issues - adverse events, device deficiencies, signal detection and immediate-action procedures.
• Documentation and data control - source documents, subject identification logs, traceability, electronic clinical data systems, and document retention.
• Accountability and quality assurance - investigational device accountability, auditing, and clinical quality management.
• Study close‑out and reporting - routine close‑out, suspension/termination procedures, clinical investigation report, and risk assessment conclusions.
• Roles and responsibilities - clear definitions for the sponsor, principal investigator, ethics committees and regulatory authorities.

Practical applications and who uses this standard

ISO 14155:2020 is essential for:

• Medical device manufacturers and sponsors planning clinical investigations (pre‑market or post‑market).
• Clinical investigators, site staff and Contract Research Organizations (CROs) conducting device trials.
• Ethics committees, institutional review boards and regulatory authorities assessing study conduct and subject protection.
• Quality assurance and regulatory affairs teams ensuring compliance with GCP and documentation practices.
• SaMD developers needing to demonstrate analytical validity, scientific validity and clinical performance where relevant.

Using ISO 14155 improves study design, regulatory acceptance, patient safety and data credibility - supporting conformity assessment, regulatory submissions and market access.

Related standards and considerations

• Users should consider applicable national/regional regulations and other relevant standards; where requirements differ, the most stringent shall apply.
• Note: ISO 14155 does not apply to in vitro diagnostics (IVDs), though some sections might be relevant depending on national requirements.

Keywords: ISO 14155:2020, clinical investigation, good clinical practice, medical devices, SaMD, clinical investigation plan, adverse events, informed consent, device accountability, clinical trial monitoring.