What is ISO 14155?

ISO 14155 specifies good clinical practice for clinical investigations of medical devices involving human subjects. It covers the design, conduct, recording and reporting of investigations used to assess a device’s clinical performance, effectiveness and safety.

The standard establishes requirements for protecting the rights, safety and well-being of subjects, while supporting scientifically sound investigations and credible clinical evidence. It also defines the responsibilities of sponsors and principal investigators and provides a common reference for ethics committees, regulatory authorities and other organizations involved in medical device conformity assessment.

ISO 14155 can also be applied, where relevant, to post-market clinical investigations and to clinical investigations involving Software as a Medical Device. It does not apply directly to in vitro diagnostic medical devices, although some requirements may be considered where permitted by national or regional rules.

Why is ISO 14155 important?

Reliable clinical evidence is essential for demonstrating that a medical device performs as intended and can be used safely. Weak investigation design, inconsistent data collection or inadequate subject protection can undermine results, delay regulatory review and create significant ethical and operational risks.

ISO 14155 helps organizations establish a consistent approach to good clinical practice across investigation sites, sponsors and stakeholders. It supports clearer oversight, stronger risk management and more credible evidence for regulatory and conformity assessment activities.

The latest edition also strengthens requirements in areas such as residual risk assessment, data monitoring, clinical events committees, adverse event reporting, missing data, estimands and the management of risks arising from clinical procedures.

Benefits

• Stronger protection of the rights, safety and well-being of clinical investigation subjects
• More scientifically robust investigation design and credible clinical evidence
• Clearer sponsor, investigator and oversight responsibilities
• Improved management of device-related and procedure-related risks
• More consistent recording, analysis and reporting of clinical data
• Stronger support for regulatory review and conformity assessment

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