DIN EN ISO 14155:2026-08

What is DIN EN ISO 14155 about?

DIN EN ISO 14155 specifies requirements for the planning, conduct, documentation and evaluation of clinical investigations of medical devices. The standard describes the principles of Good Clinical Practice (GCP) and supports the safe, ethical and scientifically sound conduct of clinical studies involving medical devices.

It serves as a key basis for collecting reliable clinical data and supports manufacturers, sponsors and investigation sites in the clinical evaluation of medical devices. This makes it one of the most important international standards in the field of clinical investigation of medical devices and regulatory requirements for medical devices.

What topics does the standard cover?

DIN EN ISO 14155 describes the requirements for clinical investigations across the entire study cycle – from study planning and risk assessment to data evaluation and final reporting. Ethical, scientific and organizational requirements are considered equally.

Topics covered at a glance:

• Clinical investigation and clinical study involving medical devices
• Good Clinical Practice (GCP) and ethical requirements
• Protection, safety and rights of study participants
• Roles and responsibilities of the sponsor, investigator and monitor
• Risk management and clinical evaluation of medical devices
• Data collection, documentation and quality management
• Monitoring, auditing and reporting of clinical investigations

Why is the standard relevant in practice?

DIN EN ISO 14155 provides an internationally recognized framework for conducting clinical investigations of medical devices and applying Good Clinical Practice (GCP). It supports the generation of reliable clinical data and promotes the quality, comparability and traceability of study results.

The standard is particularly important for the clinical evaluation of medical devices, the demonstration of safety and performance, and the preparation of regulatory procedures. Through its defined requirements for study design, risk management, monitoring, data management and quality management, it supports compliance with high scientific and regulatory standards.

What changes have been made compared with the previous edition?

Compared with the previous edition, the standard has been further developed in several areas and adapted to current regulatory requirements. The main changes include:

• Updated requirements for risk management in clinical investigations
• Expanded specifications for sponsors, investigators and monitoring processes
• Clarifications on data collection and documentation in clinical studies
• Adaptations to current regulatory frameworks for medical devices
• Revision of terms, role descriptions and responsibilities
• Stronger consideration of risk-based approaches for monitoring and quality management

Target audience

• Manufacturers and sponsors of medical devices
• Professionals in clinical research, regulatory affairs and quality management
• Investigators, study sites and research institutions
• Monitors, auditors and contract research organizations (CROs)
• Professionals responsible for clinical evaluation, approval and compliance of medical devices

Conclusion

DIN EN ISO 14155 is the key standard for Good Clinical Practice (GCP) in clinical investigations of medical devices. It supports the safe, ethical and scientifically sound conduct of clinical studies involving medical devices and provides an important basis for the clinical evaluation of medical devices, the demonstration of safety and performance, and compliance with regulatory requirements.

This document replaces DIN EN ISO 14155:2021-05 .