Present and future developments regarding the regulatory framework for medical devices in Europe

Abstract

Abstract: A general overview of the medical devices industry's trends and the related regulatory framework in Europe. Background: The medical device industry is essential for promoting and enhancing the overall quality of life and improving healthcare outcomes and is characterized by competitiveness and innovation. Medical devices have seen a major change in the healthcare sector during the last several decades. Considering the rapid growth of this industry and the latest developments in this regard, present and future considerations related to the field have been taken into account. Aim: The purpose of this master thesis is to recognize the importance of medical devices; providing a mirror of the situation and its coverage in Europe, the history of how the medical device industry has started and evolved in the world and especially with the description of the current and future developments in the field, digital transformation, as well as a general overview regarding the legal framework for medical devices in Europe. Methods: The master thesis is based on the literature review of the present legislation of medical devices in force in Europe and beyond on the latest developments related to the field. The sources of information mainly include the Regulation (EU) 2017/745 on medical devices; Regulation (EU) 2017/746 on in vitro diagnostic medical devices and guidance documents, as well as other materials published on the official websites of the European Commission, European Parliament, Statista and other official websites of national competent authorities and other institutions of European countries. Results and conclusions: The Regulation (EU) 2017/745 and Regulation (EU) 2017/746 serve as the cornerstone of the EU regulatory framework for medical devices, enhancing patient safety and device performance for the benefit of patients/users and the general public. Initiatives undertaken at EU level and country level are considered important in order that all the patients will be able to benefit from the availability of safe and innovative medical devices in Europe. Present and future developments in the field are expected to transform the industry and the system in the upcoming years and we are eager to witness the revolutionization

Date of Award	22 Sept 2023
Original language	English
Awarding Institution	University of Namur
Supervisor	Paul Piscoi (Supervisor)