Post-Market Clinical Follow-Up Study of The Selected Medical Device In European Union, Australia and United States

Abstract

The phrase "medical device" refers to a broad variety of products, ranging from highly advanced computerized medical equipment and diagnostic medical devices to therapeutic medical devices that exert their effects locally, such as tissue cutting, wound wrapping, or propping open clogged arteries. The Global Harmonization Task Force (GHTF) was established in 1992 by five members: the European Union, the United States, Australia, Japan, and Canada. Its goals were to achieve uniformity among national medical device regulatory systems and increase access to safe, efficient, and clinically advantageous medical technologies. The GHTF and all regulated nations have established specific definitions for medical devices. Despite GHTF's efforts to harmonize national laws throughout its member nations regarding medical devices, considerable disparities remain. Additionally, regulated nations have classified medical devices on the basis of their associated risk. New post-market clinical follow-up (PMCF) regulations for medical devices have been introduced as a result of the European Union(EU) Medical Devices Regulation (MDR). Under the Medical Devices Directives (MDD), monitoring complaints and doing literature searches was frequently sufficient; however, a more proactive strategy is needed today. Manufacturers can gather clinical data for CE-marked devices in a number of ways, including user surveys, data collection through registries, or PMCF studies. The PMCF plan includes a justification of each planned activity's appropriateness in addition to a list of all planned activities. The PMCF study is an essential component of the device's life cycle management and is required to ensure that the device remains safe and effective throughout its use in clinical practice. The results of the PMCF study are used to update the device's Instructions for Use (IFU) and to support its continued approval in the market. This document specifically focuses on post-market procedures in the United States(US), Australia, and the European Union. It also offers insightful information on the comparison between these countries regarding various parameters such as regulatory body involved, fees applicable, time duration of submission of documents and approval, adverse event reporting, recall, and many such criteria. This also includes the case study of medical device post-market clinical follow-up study carried out according to the investigational plan.