What is EN ISO 14155:2011?

EN ISO 14155:2011 is an international standard that provides guidelines for the design, conduct, recording, and reporting of clinical investigations carried out on medical devices. It specifically focuses on clinical investigations involving human subjects. This standard outlines the general principles and requirements for clinical investigations to ensure the protection of the rights, safety, and well-being of the patients involved.

Importance of EN ISO 14155:2011

The primary objective of implementing EN ISO 14155:2011 is to ensure the reliability and validity of clinical investigation data on medical devices. By following this standard, manufacturers can demonstrate the safety and effectiveness of their products before they are brought to market. It provides a comprehensive framework for conducting clinical investigations in a consistent and ethical manner, minimizing potential risks to patients and ensuring high-quality data collection and analysis.

Key Requirements of EN ISO 14155:2011

This standard emphasizes several key requirements that must be met during the entire process of a clinical investigation. These requirements include:

Ethics Committee Approval: Before starting a clinical investigation, it is essential to obtain approval from an ethics committee or institutional review board (IRB). The committee ensures that the study is conducted ethically and according to the principles outlined in the standard.

Informed Consent: All participants must provide informed consent before participating in the clinical investigation. They should be fully informed about the purpose, procedures, potential risks, and benefits of the study before making a decision.

Study Design: The standard provides guidance on selecting the appropriate study design based on the intended purpose and objectives of the investigation. It also highlights the importance of sample size calculation and randomization to ensure statistical validity.

Data Collection and Reporting: EN ISO 14155:2011 emphasizes the need for accurate and complete data collection throughout the investigation. It also outlines the requirements for reporting adverse events, analysis methods, and confidentiality of collected data.

Conclusion

EN ISO 14155:2011 is a crucial standard for regulating clinical investigations on medical devices involving human subjects. By adhering to its guidelines, manufacturers can ensure the safety and effectiveness of their products while maintaining ethical practices. This standard provides a solid framework for conducting high-quality and reliable clinical investigations, ultimately benefiting both patients and the medical device industry as a whole.