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Public Health

Medical Devices - Sector

Overview
Medical devices and In Vitro Diagnostic medical devices (IVDs) have a fundamental role in saving lives by providing innovative healthcare solutions…
Directives
The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...
New Regulations
The EU revised the laws governing medical devices and in vitro diagnostics to align with the developments of the sector over the last 20 years.
EUDAMED
EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices.
In Vitro Diagnostics
In vitro diagnostic medical devices (IVDs) are tests used on biological samples to determine a person's health status.
Expert panels
Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on In Vitro Medical Devices (IVDR) require the European Commission to create expert panels to support scientific assessment and advice.
Topics of Interest
A number of different topics are relevant for the implementation of the Medical Devices Regulations.

Documents