What is EN ISO 14155:2021

EN ISO 14155:2021 is a technical standard that provides guidelines for the design, conduct, recording, and reporting of clinical investigations carried out on medical devices. It specifically focuses on clinical investigations related to the evaluation of safety and performance in order to assess whether a medical device is suitable for its intended purpose.

Key Objectives of EN ISO 14155:2021

The primary objective of EN ISO 14155:2021 is to ensure the protection of human subjects participating in clinical investigations. This includes safeguarding their rights, safety, dignity, and well-being throughout the study. The standard also aims to uphold data integrity and ensure that the results obtained from these investigations are reliable and robust.

Implementation of EN ISO 14155:2021

Implementing EN ISO 14155:2021 requires adherence to a set of comprehensive guidelines. These guidelines cover various aspects such as ethical considerations, study design, subject selection, informed consent, and risk management. The standard emphasizes the need for thorough documentation, including protocols, investigator brochures, and essential study documents.

Furthermore, EN ISO 14155:2021 highlights the importance of appropriately qualified personnel involved in the conduct of clinical investigations. It defines the roles and responsibilities of investigators, sponsors, monitors, and ethics committees, emphasizing the need for clear communication and collaboration among all parties.

Benefits of EN ISO 14155:2021 Compliance

Compliance with EN ISO 14155:2021 offers several benefits. Firstly, it ensures that clinical investigations are conducted in a standardized and consistent manner, which enhances comparability of data across studies. This facilitates knowledge sharing and decision-making processes regarding the safety and performance of medical devices.

Secondly, the standard promotes patient safety by emphasizing ethical considerations and risk management. It ensures that potential risks associated with the investigational device are identified, evaluated, and managed effectively. This minimizes the potential harm to study participants and enhances the overall quality of clinical investigations.

Lastly, compliance with EN ISO 14155:2021 instills confidence among stakeholders, such as regulatory authorities, patients, and healthcare professionals. It demonstrates a commitment to upholding high standards in clinical research and provides assurance that the data generated from these investigations are reliable, credible, and can be used for decision-making purposes.