The impact of the European medical device regulations EU 2017/745 and EU 2017/746 on Business Management and Insights of the maturity of quality management systems of the organizations for regulatory purposes

Abstract

The thesis examines the impact that adhering to the European medical device regulations EU 2017/745 and EU 2017/745 has on medical device manufacturers with focus on a business management and the development quality management systems for regulatory purposes. The objective was to explore the experiences and maturity levels of the organization to be complying with requirements related to manufacturer´s responsibility. Also, it provides an insight into how alignment to international standards enables organization to meet requirements by regulation. This research was conducted to address the increasing demands placed on medical device manufacturers by evolving European legislation and to provide insights into how these demands influence organizational compliance efforts. Also to understand the implicit cost, maturity levels and have a better understanding of experiences and challenges of organizations. The results demonstrate that organizations are adopting robust compliance strategies and have experienced significant improvements in their quality management systems, which leads to enhanced operational efficiency and market reputation. Compliance with EU 2017/745 and EU 2017/746 not only ensures product safety and effectiveness but also enables market access to all member states and export to third countries that recognize and trust the European CE marked products.