Global market and supply chain implications of the European Union medical device regulation 2017/745 as amended by 2023/607.

Abstract

The release of the European Union Medical Device Regulations (EU MDR) has introduced many complexities for medical device manufacturers and has had implications for their global markets; one such complexity was the unforeseen consequence of the impact which the MDR has imposed on country registrations held outside the European jurisdiction, as certain countries abridge the Conformité Européene (CE) mark for market authorization purposes. This study focuses on the global implications for medical