What is EN ISO 14155:2021?

EN ISO 14155:2021 is a professional technical standard that provides guidelines for the design, conduct, recording, and reporting of clinical investigations carried out on medical devices.

Why is EN ISO 14155:2021 important?

EN ISO 14155:2021 is crucial for ensuring the safety, efficacy, and quality of medical devices. It helps to establish clear and standardized procedures for conducting clinical investigations, which are necessary for evaluating the performance and potential risks of new medical devices before they are made available to the public.

By following the guidelines set forth in EN ISO 14155:2021, companies can ensure that their clinical investigations meet the necessary ethical and scientific standards. This not only protects the rights and safety of patients involved in the studies but also provides reliable data on the effectiveness and safety profiles of medical devices.

Key elements of EN ISO 14155:2021

The standard covers various aspects of clinical investigations, including study design, participant selection, informed consent, data management, and adverse event reporting. It emphasizes the need for a well-defined protocol and clear documentation throughout the entire process.

EN ISO 14155:2021 also highlights the importance of complying with applicable regulatory requirements and obtaining the necessary approvals from regulatory authorities and ethics committees. It promotes transparency, reliability, and consistency in the conduct and reporting of clinical investigations.

Conclusion

EN ISO 14155:2021 plays a vital role in ensuring the safety and effectiveness of medical devices. By following its guidelines, manufacturers can conduct high-quality clinical investigations that provide valuable data for regulatory submissions and decision-making processes. Compliance with this standard enhances patient protection, fosters innovation, and boosts overall confidence in the medical device industry.