What is EN ISO 14155:2021?

EN ISO 14155:2021 is a standard published by the European Committee for Standardization (CEN) that provides guidelines for conducting clinical investigations on medical devices involving human subjects. This standard applies to both manufacturers and researchers involved in clinical research, ensuring adherence to ethical principles and maintaining patient safety throughout the process.

Key objectives of EN ISO 14155:2021

The primary goal of EN ISO 14155:2021 is to provide a harmonized framework for clinical investigations on medical devices. It aims to ensure the scientific validity of the study results, as well as the protection of the rights, safety, and well-being of the participating patients. This standard emphasizes the need for well-designed trials and robust data collection to facilitate accurate analyses and reliable conclusions.

Main components of EN ISO 14155:2021

EN ISO 14155:2021 consists of several key components that contribute to its effective implementation:

1. General requirements: This section lays out the fundamental principles and considerations applicable to all clinical investigations on medical devices.

2. Ethics: Ethical aspects play a crucial role in any clinical investigation. This standard provides guidance on obtaining informed consent, ensuring privacy and confidentiality, managing conflicts of interest, and addressing potential risks or benefits for participants.

3. Design and methodological considerations: Proper study design and appropriate methodologies are essential for generating reliable and meaningful results. EN ISO 14155:2021 offers guidelines on selecting appropriate study populations, defining endpoints, and analyzing and reporting data.

4. Sponsor responsibilities: The standard outlines the obligations of the sponsor, who is responsible for initiating, managing, and reporting on the clinical investigation. This includes ensuring compliance with regulatory requirements, overseeing data management, maintaining study documentation, and assessing potential risks throughout the investigation.

Conclusion

The EN ISO 14155:2021 standard plays a vital role in promoting high-quality and ethical clinical investigations involving medical devices. By providing guidance on various aspects of the study process, it ensures patient safety, reliable results, and adherence to ethical considerations. Manufacturers and researchers should familiarize themselves with this standard to ensure compliance and contribute to the advancement of medical knowledge while safeguarding the well-being of patients.