What is EN ISO 14155:2011?

EN ISO 14155:2011 is an international standard that provides guidelines on the design, conduct, and reporting of clinical investigations for medical devices. It aims to ensure the protection of patients' rights, safety, and well-being during these investigations.

The Purpose of EN ISO 14155:2011

The primary purpose of EN ISO 14155:2011 is to harmonize the requirements for conducting clinical investigations on medical devices in order to guarantee the reliability and credibility of the data collected. This standard helps in establishing a common framework that ensures the ethical conduct of such investigations, regardless of the country or organization involved.

Key Components and Requirements

EN ISO 14155:2011 covers various aspects related to the planning, execution, and reporting of clinical investigations. Some of the key components and requirements outlined in this standard include:

Ethics Committee Approval: Prior approval from an independent ethics committee is necessary before initiating any clinical investigation, ensuring that the study meets ethical standards and offers potential benefits to the patients.

Informed Consent: Informed consent must be obtained from all participants before their inclusion in the investigation. They should be provided with clear information about the nature, risks, and possible consequences of the investigation.

Investigator Responsibilities: The investigators are responsible for ensuring the safety and well-being of the participants throughout the investigation. They must ensure proper documentation, compliant with applicable regulatory requirements, and monitor adverse events.

Data Integrity: There should be systems in place to ensure the accuracy, completeness, and consistency of the collected data. This includes proper documentation, record-keeping, and data handling procedures.

Benefits and Implications

Adhering to the guidelines set forth in EN ISO 14155:2011 brings several benefits to all stakeholders involved in clinical investigations. Firstly, it ensures patient safety by establishing clear protocols and standards that investigators must follow. Secondly, it increases the reliability of the collected data, which is crucial for regulatory submissions and decision-making processes. Thirdly, it facilitates international cooperation and harmonization in the field of medical device research, making it easier to compare and exchange information across different countries and organizations.

Overall, EN ISO 14155:2011 plays a significant role in ensuring the ethical and high-quality conduct of clinical investigations for medical devices. By following this standard, researchers, clinicians, and manufacturers can contribute to the development of safe and effective medical devices that ultimately benefit patients around the world.