BS EN ISO 14155:2026

This standard BS EN ISO 14155:2026 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 specifies good clinical practice (GCP) 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 the general requirements intended to protect the rights, safety and well-being of human subjects, users or other persons, ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices. Other standards or national requirements can also apply to the investigational device(s) under consideration or the clinical investigation(s). NOTE            For Software as a Medical Device (SaMD), where appropriate, demonstration of the analytical validity (the SaMD’s output is accurate for a given input), the scientific validity (the SaMD’s output is associated to the intended clinical condition/physiological state), and clinical performance (the SaMD’s output yields a clinically meaningful association to the target use) of the SaMD, the requirements of this document apply as far as relevant (see Reference [5]). Justifications for exemptions from this document can consider the uniqueness of indirect contact between subjects and the SaMD. 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 can consider whether either specific sections or requirements of this document, or both, can be applicable.

BS EN ISO 14155:2026 - Clinical Investigation of Medical Devices for Human Subjects. Good Clinical Practice

Introducing the BS EN ISO 14155:2026, a comprehensive standard that sets the benchmark for clinical investigations of medical devices involving human subjects. This essential document is designed to ensure that clinical trials are conducted with the utmost integrity, safety, and scientific rigor, adhering to the principles of good clinical practice.

Overview

The BS EN ISO 14155:2026 standard is a pivotal resource for professionals involved in the clinical investigation of medical devices. Released on April 22, 2026, this document provides a detailed framework for conducting clinical trials, ensuring that they meet the highest ethical and scientific standards. With 108 pages of in-depth guidelines, this standard is indispensable for anyone involved in the development, testing, and approval of medical devices.

Key Features

• Standard Number: BS EN ISO 14155:2026
• Pages: 108
• Release Date: April 22, 2026
• ISBN: 978 0 539 25365 8
• Status: Standard

Why Choose BS EN ISO 14155:2026?

This standard is crucial for ensuring that clinical investigations are conducted in a manner that protects the rights, safety, and well-being of human subjects. It provides a robust framework for the design, conduct, recording, and reporting of clinical investigations, ensuring that the data generated is credible and accurate.

Ethical Considerations

The BS EN ISO 14155:2026 emphasizes the importance of ethical considerations in clinical investigations. It outlines the responsibilities of sponsors, investigators, and ethics committees to ensure that the rights and welfare of participants are prioritized. This includes obtaining informed consent, ensuring confidentiality, and minimizing risks to participants.

Scientific Integrity

Scientific integrity is at the core of the BS EN ISO 14155:2026 standard. It provides detailed guidance on the design and conduct of clinical investigations, ensuring that they are scientifically sound and capable of producing reliable data. This includes recommendations on study design, data management, and statistical analysis.

Regulatory Compliance

Compliance with regulatory requirements is a critical aspect of clinical investigations. The BS EN ISO 14155:2026 standard aligns with international regulations, providing a harmonized approach to clinical investigations. This ensures that studies conducted under this standard are recognized and accepted by regulatory authorities worldwide.

Who Should Use This Standard?

The BS EN ISO 14155:2026 is an invaluable resource for a wide range of professionals involved in the clinical investigation of medical devices, including:

• Clinical researchers and investigators
• Medical device manufacturers
• Regulatory affairs professionals
• Ethics committee members
• Quality assurance personnel

Conclusion

The BS EN ISO 14155:2026 standard is an essential tool for ensuring the ethical and scientific integrity of clinical investigations involving medical devices. By adhering to this standard, professionals can ensure that their studies are conducted in a manner that protects participants and produces reliable, credible data. Whether you are a researcher, manufacturer, or regulatory professional, this standard is a must-have resource for navigating the complex landscape of clinical investigations.

Invest in the BS EN ISO 14155:2026 standard today and ensure that your clinical investigations meet the highest standards of good clinical practice.