BS EN ISO 14155:2020+A11:2024 - Clinical Investigation of Medical Devices for Human Subjects

Standard Number: BS EN ISO 14155:2020+A11:2024

Pages: 108

Released: 2025-01-17

ISBN: 978 0 539 35059 3

Status: Standard

Overview

The BS EN ISO 14155:2020+A11:2024 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.

Key Features

• Comprehensive Guidelines: This standard offers detailed guidance on the planning, conduct, recording, and reporting of clinical investigations.
• Focus on Safety and Ethics: Emphasizes the importance of ethical considerations and the protection of human subjects involved in clinical trials.
• International Applicability: As an ISO standard, it is recognized and applicable internationally, facilitating global harmonization in clinical investigations.
• Updated Content: The 2024 amendment ensures that the standard reflects the latest advancements and regulatory requirements in the field of medical device clinical investigations.

Why Choose BS EN ISO 14155:2020+A11:2024?

Choosing the BS EN ISO 14155:2020+A11:2024 standard is a strategic decision for any organization involved in the development and testing of medical devices. Here are some reasons why this standard is indispensable:

• Ensures Compliance: Adhering to this standard helps organizations comply with regulatory requirements, reducing the risk of non-compliance penalties.
• Enhances Credibility: Following internationally recognized guidelines enhances the credibility and acceptance of clinical investigation results.
• Improves Patient Safety: By prioritizing the safety and well-being of human subjects, this standard helps improve patient outcomes and trust in medical devices.
• Facilitates Market Access: Compliance with this standard can facilitate smoother market access and acceptance in various regions around the world.

Content Structure

The standard is structured to provide a logical flow of information, making it easy to follow and implement. It includes sections on:

1. General Requirements
2. Ethical Considerations
3. Clinical Investigation Planning
4. Conduct of Clinical Investigations
5. Data Management and Reporting
6. Responsibilities of Sponsors and Investigators

Who Should Use This Standard?

This standard is designed for a wide range of stakeholders in the medical device industry, including:

• Medical Device Manufacturers
• Clinical Research Organizations
• Regulatory Affairs Professionals
• Clinical Investigators and Researchers
• Ethics Committees

Conclusion

The BS EN ISO 14155:2020+A11:2024 standard is an essential tool for anyone involved in the clinical investigation of medical devices. Its comprehensive guidelines ensure that investigations are conducted ethically and scientifically, providing reliable data that can be used to improve patient care and advance medical technology. By adhering to this standard, organizations can enhance their credibility, ensure compliance, and ultimately contribute to the development of safer and more effective medical devices.

BS EN ISO 14155:2020+A11:2024

This standard BS EN ISO 14155:2020+A11:2024 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 AnnexI). This document specifies general requirements intended to - protect the rights, safety and well-being of human subjects, - 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. NOTE1 Users of this document need to consider whether other standards and/or national requirements also apply to the investigational device(s) under consideration or the clinical investigation. If differences in requirements exist, the most stringent apply. NOTE2 For Software as a Medical Device (SaMD) demonstration of the analytical validity (the SaMD’s output is accurate for a given input), and where appropriate, 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[4]). 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, whereusers of this document might consider whether specific sections and/or requirements of this document could be applicable.