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…

The importance of certifying medical devices under MDR

The new Regulation (EU) 2017/745 or MDR is the European medical device regulation that defines regulations and constraints that all manufacturers and distributors must comply with in order to place a medical device on the European market. The new Regulation complements and replaces the previous Directives 90/385/EEC and 93/42/EEC, providing more stringent requirements and measures…