期刊名称：Journal of Open Innovation: Technology, Market, and Complexity
电子版ISSN：2199-8531
出版年度：2020
卷号：6
期号：2
页码：1-13
DOI：10.3390/joitmc6020042
语种：English
出版社：Springer
摘要：In the Czech Republic, the medical device industry is an important sector with a strong tradition and has high added value and perspectives in demand under changing demographic and social structures. The aim of this article is to describe and analyze the complex issues of the new European Commission Medical Device Regulation (MDR) 2017/745 from the perspective of the strategic decisions of companies that have to comply with the requirements imposed on them by the new legislation and at the same time fulfill their own business needs and goals. The legislative changes significantly affect the standards, processes, and certifications in the medical device sector. The classification system of medical devices has been revised to more appropriately reflect the possible health risks associated with use of modern high-end technology in healthcare. The requirement is to categorize each device under the highest possible risk class, which means for the medical device manufacturers to carefully review the new rules and regulations and classify their devices accordingly.
关键词：medical devices; regulatory; European Commission; development; market
