Legislation of Ukraine requirements on verification of medical devices with measuring function

Abstract

This article addresses the necessity of verifying medical devices with measuring functionality, highlights key legislative changes, and underscores the requirements for verification at the time of deployment/usage and throughout the operational lifespan of medical devices involving measuring functions. Legislative changes have led to a lack of awareness among healthcare facilities using medical devices with measuring functions regarding the regulatory requirements, ensuring measurement accuracy for proper diagnosis, diagnostics, monitoring, and treatment. Therefore, familiarity with legislation and adherence to established requirements enable the implementation of preventive measures to safeguard public health and safety while minimizing risks associated with the use of medical devices. Thus, this article is crucial for enhancing awareness regarding the verification requirements for medical devices with measurement functions and for the proper fulfillment of responsibilities by facilities employing such medical devices with measuring functions.