Medical Devices - Sector

Medical devices and In Vitro Diagnostic medical devices (IVDs) have a fundamental role in saving lives by providing innovative healthcare solutions…

The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...

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 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 diagnostic medical devices (IVDs) are tests used on biological samples to determine a person's health status.

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.