BS EN ISO 14155-2:2019

The field of clinical research is continuously evolving, with new standards and guidelines regularly being established to ensure the safety and efficacy of medical devices and therapies. One such standard is BS EN ISO 14155-2:2019, which provides requirements for the conduct of clinical investigations of medical devices in human subjects. This article aims to provide an easy-to-understand explanation of BS EN ISO 14155-2:2019 and its implications for clinical research.

Understanding the Scope

BS EN ISO 14155-2:2019 focuses on the initiation, design, conduct, recording, and reporting of clinical investigations involving medical devices. It provides guidance on different aspects, including ethical considerations, risk assessment, and participant protection. The standard applies to all types of medical devices, ranging from simple bandages to complex implantable devices.

Key Requirements of BS EN ISO 14155-2:2019

1. Ethical considerations: The standard emphasizes the importance of obtaining informed consent from participants and ensuring their rights, safety, and well-being throughout the study. It also highlights the need for unbiased selection of participants and equitable distribution of benefits and burdens.

2. Risk management: BS EN ISO 14155-2:2019 requires appropriate risk management strategies during clinical investigations. This involves identifying, assessing, and mitigating risks associated with the device under investigation and the study itself.

3. Data collection and analysis: The standard provides guidelines for collecting accurate and reliable data during clinical investigations. It emphasizes the use of appropriate statistical methods for data analysis to ensure valid conclusions are drawn.

4. Study documentation and reporting: BS EN ISO 14155-2:2019 requires clear and thorough documentation of the clinical investigation process, including study protocols, data collection forms, and adverse event reporting. This promotes transparency and traceability of the study.

Implications for Clinical Research

BS EN ISO 14155-2:2019 plays a crucial role in ensuring the quality and integrity of clinical investigations involving medical devices. Compliance with this standard is essential for researchers, sponsors, and regulatory authorities to demonstrate that their studies are conducted ethically and scientifically rigorous. By adhering to BS EN ISO 14155-2:2019, we can maintain public trust in clinical research and ultimately enhance patient safety and well-being.