Eudamed: Introduction to Its Gradual Implementation

A New Standard for Transparency and Traceability in Medical Devices Regulation (EU) 2024/1860 has introduced significant changes to MDR (EU) 2017/745 and IVDR (EU) 2017/746, facilitating the gradual implementation of Eudamed, the European database on medical devices. This system marks a crucial step towards greater transparency, traceability, and safety in the healthcare sector. Since July…

MDR: The new roles of economic actors

Economic players, new definitions, and the roles players can play in the medical device market With the adoption of European Regulations 2017/745 MDR (Medical Device Regulation) and 2017/746 IVDR (In Vitro Diagnostic Regulation), the regulations for medical devices and in vitro medical devices have changed dramatically. With the MDR regulation, the figures of traders were,…