What is EN ISO 14155:2021?

EN ISO 14155:2021 is an international standard that provides guidelines for the conduct of clinical investigations with medical devices. It sets out the requirements and recommendations for the design, conduct, recording, and reporting of clinical investigations in human subjects.

Importance of EN ISO 14155:2021

The purpose of EN ISO 14155:2021 is to ensure the protection of human rights, safety, and well-being during the course of clinical investigations. Compliance with this standard is essential for any organization involved in conducting clinical studies with medical devices.

This standard helps to establish a framework for ethical and scientific quality in the planning, execution, supervision, monitoring, analysis, and reporting of clinical investigations.

Key Requirements of EN ISO 14155:2021

EN ISO 14155:2021 covers various aspects of clinical investigations with medical devices, including:

General principles for clinical investigation of medical devices

Responsibilities of sponsors, investigators, and ethics committees

Informed consent and ethical considerations

Designing and conducting clinical investigations

Risk management and data protection

Monitoring and reporting of adverse events

Benefits of Compliance

Compliance with EN ISO 14155:2021 offers several advantages. Firstly, it ensures that the rights, safety, and well-being of study participants are protected throughout the clinical investigation process. Secondly, it enhances the credibility and reliability of the study results, thereby enabling better decision-making regarding the safety and effectiveness of the medical device under investigation.

Moreover, adherence to this standard promotes consistency and harmonization in the conduct of clinical investigations, facilitating data exchange and comparison across studies. It also helps organizations meet regulatory requirements and gain market access for their medical devices.

In conclusion, EN ISO 14155:2021 plays a vital role in ensuring the ethical and scientific quality of clinical investigations with medical devices. By adhering to this standard, organizations can safeguard human rights while generating reliable and trustworthy results. Compliance ultimately contributes to improved patient safety and the advancement of medical technology.