Establishing a patient centred medical device body

Abstract

In the rapidly evolving landscape of healthcare, the field of medical devices plays a pivotal role in advancing patient safety and enhancing the quality of life. Recent developments in technology and regulatory frameworks have prompted a transition in medical device legislation. The directives governing medical devices and in-vitro diagnostic devices were superseded by the Medical Device Regulation (MDR - (EU) 2017/745) and the In-Vitro Diagnostic Medical Device Regulation (IVDR - (EU) 2017/746), signalling a change in the regulatory landscape. This research endeavours to contribute to this transformative phase by creating a framework for a patient-centred medical device body. The overarching goal is to develop a transition framework for medical device regulation, facilitating stakeholders in understanding and complying with the new regulatory requirements. The methodology is split into four phases. The initial phase focuses on establishing a Medical Device Quality Management System, identifying fundamental regulatory requirements essential for supporting a patient-centred framework. The second phase of the study delves into the development of a centralised Medical Device Incident Reporting System, streamlining processes and procedures for incident reporting functionality in the medical device domain. The third phase is dedicated to setting up a Digital Medical Device Management System (MDMS), addressing production, notification, distribution, vigilance, and surveillance of medical devices placed on the market. The MDMS is designed to enhance transparency and accessibility, allowing stakeholders and the public to verify devices, report adverse events, and contribute to an increased market access for all. The fourth phase focuses on identifying gaps for essential medical device training and continuous professional development, ensuring that medical device operators are well-equipped to navigate the evolving regulatory landscape. The impact of this study is to put forward a robust framework for bodies to propose innovative legislative transition solutions whilst fostering a patient-centred approach in the implementation of new regulations. This research seeks to contribute to the ongoing enhancement of patient care and well-being through a well-defined, patient-centric medical device regulatory framework.