Clinical investigations play an important role in your journey of bringing a medical device to market. The regulatory requirements for medical device clinical trials can be overwhelming, but having a clear understanding of the related standards can help to simplify the process and make it less overwhelming.
Clinical performance studies are essential for In-Vitro Diagnostic devices when traditional analytical performance studies or literature research methods are not sufficient to evaluate the performance of the IVD device. In 2019 ISO 20916: 2019 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice was published and provided clear guidelines on the design and management of performance studies for IVD devices.
The IVDR 2017/746 has addressed specific requirements for clinical performance outlined in articles 57 to 77 and Annex XIII, section 2. ISO 20916 offers additional guidance on how to meet the requirements specified in the IVDR. Every IVD device manufacturer that is either planning to conduct or is already conducting clinical performance studies should carefully review ISO 20916 and comply with the standard.
For clinical evaluation of Medical Devices standard ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice is relevant. This document outlines the principles of good clinical practice for the design, execution, documentation, and reporting of clinical trials involving human subjects. The purpose of these trials is to evaluate the clinical performance, effectiveness, and safety of medical devices. This guide offers direction to both manufacturers and clinical research professionals on how to adhere to Good Clinical Practice for both pre- and post-market clinical trials, aimed at evaluating the safety and performance of medical devices.
Anyone involved in clinical trials should have access to the relevant standards. The Estonian Center for Standardization and Accreditation offers copies of these standards at a more affordable price than the official ISO website or other sources. The standards are available in English.
In conclusion, clinical performance and evaluation studies play a critical role in the development and market launch of IVD and MD. Adherence to relevant standards, such as ISO 20916 and ISO 14155, can help ensure effective and compliant clinical trials.