What is BS EN ISO 14155:3 2019?

Medical devices play a crucial role in healthcare, and ensuring their safety and efficacy is vital. This is where international standards come into play, providing guidance and requirements for various aspects of medical device development and manufacturing. One such standard is BS EN ISO 14155:3 2019, which focuses on the conduct of clinical investigations involving medical devices. In this article, we will explore the key aspects of this important standard.

Scope and Purpose

The BS EN ISO 14155:3 2019 standard specifically addresses the requirements for clinical investigations conducted to collect clinical data on medical devices intended for human use. The scope covers all phases of clinical investigations, from planning to reporting. It aims to guide researchers, manufacturers, and regulators in conducting ethical and scientifically sound clinical trials.

By adhering to this standard, stakeholders can ensure that clinical investigations meet high-quality standards and strive for reliable results. Compliance with BS EN ISO 14155:3 2019 helps promote patient safety, protect study participants' rights, and generate robust clinical evidence for medical device assessment and decision-making processes.

Key Components and Requirements

BS EN ISO 14155:3 2019 consists of several essential components and requirements that must be followed during clinical investigations. These include:

Risks and Benefits Assessment: Before initiating a clinical investigation, it is crucial to conduct a thorough evaluation of potential risks and benefits associated with the medical device. This assessment should consider both immediate and long-term effects on patients, as well as any applicable legal and ethical requirements.

Detailed Study Protocol: A comprehensive study protocol must be developed, clearly outlining the objectives, design, methodology, and analysis plan of the clinical investigation. It should also describe participant selection criteria, treatment interventions, follow-up procedures, and adverse event reporting methods.

Good Clinical Practice (GCP): Adherence to good clinical practice principles is paramount when conducting clinical investigations. GCP encompasses ethical conduct, subject safety, informed consent, data integrity, and personnel training, among other critical aspects. Following GCP guidelines ensures the reliability and credibility of the study results.

Regulatory Compliance: BS EN ISO 14155:3 2019 emphasizes the importance of compliance with relevant regulations and legislation during clinical investigations. This includes obtaining appropriate regulatory approvals and permissions, maintaining accurate records, and ensuring appropriate monitoring and auditing throughout the study.

Conclusion

BS EN ISO 14155:3 2019 serves as a valuable resource for researchers, manufacturers, and regulators involved in clinical investigations of medical devices. Its comprehensive guidance helps ensure that studies are conducted ethically, scientifically, and consistently, thereby enhancing patient safety and generating reliable clinical evidence. By adhering to the requirements outlined in this standard, stakeholders can contribute to advancements in medical device development and ultimately improve global healthcare outcomes.