BS EN ISO 14155:2020 - Clinical Investigation of Medical Devices for Human Subjects

Standard Number: BS EN ISO 14155:2020

Pages: 96

Released: 2020-11-26

ISBN: 978 0 539 16220 2

Status: Standard

Overview

The BS EN ISO 14155:2020 is a comprehensive standard that provides guidelines for the clinical investigation of medical devices intended for human subjects. This standard is essential for ensuring that clinical investigations are conducted in a manner that protects the rights, safety, and well-being of human subjects, while also ensuring the scientific validity of the data collected.

Purpose and Importance

In the rapidly evolving field of medical devices, it is crucial to have a standardized approach to clinical investigations. The BS EN ISO 14155:2020 serves this purpose by outlining the principles of Good Clinical Practice (GCP). This ensures that the clinical investigations are ethically conducted and that the data generated is reliable and robust.

Good Clinical Practice is a set of internationally recognized ethical and scientific quality requirements that must be observed for designing, conducting, recording, and reporting clinical investigations that involve human subjects. Adhering to these practices is vital for gaining regulatory approval and for the successful commercialization of medical devices.

Key Features

• Comprehensive Guidelines: The standard provides detailed guidance on the planning, conduct, and reporting of clinical investigations.
• Ethical Considerations: It emphasizes the importance of ethical considerations, including informed consent and the protection of vulnerable populations.
• Risk Management: The standard includes provisions for risk management, ensuring that potential risks to subjects are minimized.
• Data Integrity: It outlines the requirements for data collection and management to ensure the integrity and reliability of the data.
• Regulatory Compliance: The standard helps ensure compliance with regulatory requirements, facilitating the approval process for new medical devices.

Who Should Use This Standard?

The BS EN ISO 14155:2020 is an invaluable resource for a wide range of stakeholders in the medical device industry, including:

• Clinical Investigators: Professionals responsible for conducting clinical investigations will find this standard essential for ensuring that their studies meet the highest ethical and scientific standards.
• Regulatory Affairs Specialists: Those involved in the regulatory approval process will benefit from understanding the requirements outlined in this standard.
• Medical Device Manufacturers: Companies developing new medical devices will need to adhere to this standard to ensure their products are safe and effective.
• Ethics Committees: Members of ethics committees will use this standard to evaluate the ethical aspects of proposed clinical investigations.

Benefits of Adhering to BS EN ISO 14155:2020

Adhering to the BS EN ISO 14155:2020 standard offers numerous benefits, including:

• Enhanced Patient Safety: By following the guidelines, investigators can ensure that the safety and well-being of human subjects are prioritized.
• Improved Data Quality: The standard's emphasis on data integrity ensures that the results of clinical investigations are reliable and can be used to support regulatory submissions.
• Streamlined Regulatory Approval: Compliance with the standard can facilitate the regulatory approval process, reducing time to market for new medical devices.
• Global Recognition: As an internationally recognized standard, adherence to BS EN ISO 14155:2020 can enhance the credibility and acceptance of clinical investigation results worldwide.

Conclusion

The BS EN ISO 14155:2020 is an essential standard for anyone involved in the clinical investigation of medical devices. By providing a comprehensive framework for Good Clinical Practice, it ensures that clinical investigations are conducted ethically and scientifically, ultimately leading to safer and more effective medical devices for patients worldwide.

Whether you are a clinical investigator, a regulatory affairs specialist, or a medical device manufacturer, understanding and adhering to this standard is crucial for success in the medical device industry.

BS EN ISO 14155:2020

This standard BS EN ISO 14155:2020 Clinical investigation of medical devices for human subjects. Good clinical practice is classified in these ICS categories:

• 11.100.20 Biological evaluation of medical devices

This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.

For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I).

This document specifies general requirements intended to

1. protect the rights, safety and well-being of human subjects,

2. ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,

3. define the responsibilities of the sponsor and principal investigator, and

4. assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

This document does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, where users of this document might consider whether specific sections and/or requirements of this document could be applicable.