Glossary · ISO and IEC standards for MedTech and pharma

ISO 14155

Also known as: ISO 14155:2020, EN ISO 14155, GCP for medical device clinical investigations

ISO 14155 is the international standard of good clinical practice for clinical investigations of medical devices in human subjects. It sets requirements for the design, conduct, recording and reporting of such investigations to protect the rights, safety and well-being of subjects and to ensure credible results.

Standards
MDR

In one sentence

ISO 14155:2020 sets good clinical practice for clinical investigations of medical devices: design, conduct, monitoring, safety reporting and reports.

Example

A sponsor of a new coronary stent writes a clinical investigation plan and investigator's brochure to ISO 14155, obtains ethics committee approval and authorization under the MDR, monitors the sites and reports adverse events per the plan.

How it applies

Legal hook: Clinical investigations under Articles 62–82 and Annex XV MDR must follow the regulation; ISO 14155 describes how to do this in practice, from planning to the final report.
Core documents: Clinical investigation plan, investigator's brochure, informed consent materials, case report forms, monitoring plan and the clinical investigation report.
Roles: Sponsor, principal investigator, monitor and ethics committee, with defined responsibilities for safety reporting and data quality.
Risk-based approach: The 2020 edition emphasizes risk-based monitoring and applies the risk management of ISO 14971 to the investigation.
Post-market studies: The standard also covers investigations after CE marking, such as PMCF studies, with requirements scaled to the study type.
Technical documentation: The clinical investigation report feeds the clinical evaluation and, for class III and implantable devices, the SSCP.

ISO 14155 vs. ICH E6(R3)

Both are GCP texts. ICH E6(R3) applies to clinical trials of medicinal products under the Clinical Trials Regulation; ISO 14155 applies to clinical investigations of medical devices under the MDR. Device investigations address device deficiencies, operator skill and iterative design, which drug trial guidance doesn't cover. Performance studies of IVDs follow ISO 20916.

Compared with the USA

In the USA, significant-risk device studies require an investigational device exemption (IDE) under 21 CFR Part 812. The FDA recognizes ISO 14155, but its own regulations on human subject protection and IDEs apply.