What is EN ISO 14155:2011?

EN ISO 14155:2011 is a technical standard that provides guidelines for the design, conduct, recording, and reporting of clinical investigations involving medical devices. This European standard applies to all types of clinical investigations, including those conducted on human subjects as well as preclinical evaluations.

Guidelines for Design and Conduct of Clinical Investigations

The standard outlines principles and practices for designing and conducting clinical investigations in relation to medical devices. It emphasizes the importance of considering ethical aspects, protection of human rights, and ensuring the safety and efficacy of medical devices before they are brought to market.

The guidelines provide detailed information on factors such as study design, sample size determination, data collection, monitoring, and statistical analysis. By following these recommendations, researchers can ensure that their clinical investigations meet high standards and produce reliable results.

Recording and Reporting

EN ISO 14155:2011 also highlights the significance of proper documentation throughout the clinical investigation process. Clear and accurate recording of all procedures, observations, and data is essential to ensure reproducibility, transparency, and accountability.

The standard requires comprehensive reporting of the clinical investigation results, including details about the methodology, findings, analysis, and any significant adverse events or device-related concerns that emerged during the study.

Preclinical Evaluations

In addition to clinical investigations involving human subjects, EN ISO 14155:2011 also covers preclinical evaluations for medical devices. These evaluations involve testing the device in animal models or using other non-human methods to assess its safety, performance, and potential risks before moving forward with clinical trials.

The standard provides guidance on appropriate study protocols, selection of relevant animal models, and ethical considerations for conducting preclinical evaluations. By adhering to these guidelines, researchers can ensure that potential risks are identified and addressed early in the development process.