What is BS EN ISO 14155-3:2019?

BS EN ISO 14155-3:2019 is an international standard that provides guidelines for the conduct of clinical investigations of medical devices in human subjects. This standard is part of a series of standards developed by the International Organization for Standardization (ISO) to ensure the safety, efficacy, and quality of medical devices.

Scope and Objectives of BS EN ISO 14155-3:2019

The scope of BS EN ISO 14155-3:2019 encompasses all clinical investigations involving medical devices, including those conducted for regulatory compliance, performance evaluation, or post-market surveillance. The standard applies to both investigational device studies and studies conducted using commercially available medical devices.

The main objectives of BS EN ISO 14155-3:2019 are to ensure the protection of human subjects participating in clinical investigations, to establish uniformity in data collection and reporting, and to promote good clinical practices.

Key Requirements of BS EN ISO 14155-3:2019

BS EN ISO 14155-3:2019 outlines several key requirements that need to be followed during the design, conduct, recording, and reporting of clinical investigations. These requirements include:

Obtaining ethical approval from appropriate authorities and informed consent from study subjects.

Ensuring the qualifications and training of investigators and other personnel involved in the study.

Implementing appropriate measures to minimize and manage risks to study subjects.

Ensuring the accuracy, completeness, and confidentiality of study data.

Monitoring the progress of the study and taking necessary actions to address deviations from the protocol.

Reporting adverse events and other study-related incidents in a timely manner.

Benefits of Compliance with BS EN ISO 14155-3:2019

Compliance with BS EN ISO 14155-3:2019 brings several benefits to both medical device manufacturers and study subjects. By following the standard's guidelines, manufacturers can ensure that their clinical investigations are conducted in an ethical and scientifically valid manner, leading to reliable and meaningful results.

For study subjects, compliance with BS EN ISO 14155-3:2019 provides assurance that their rights, safety, and well-being are protected throughout the duration of the clinical investigation. It also contributes to the overall improvement of healthcare by facilitating the development of safe and effective medical devices.