News - August 14, 2019

Medical Devices: Factsheet on UDI System

The European Commission just published a FAQ document on the new Unique Device Identification (UDI) system, as introduced by the two new Regulations on Medical Devices (2017/745) and In Vitro Diagnostics Devices (2017/746).

The document spells out the objectives of this new system, namely to facilitate easier traceability of devices, enhance the post-market safety-related activities for and help reduce medical errors and fight against falsified devices.

The factsheet will certainly be a useful instrument for all stakeholders to grasp the important changes brought by this new system of identification of devices.

For more information on EUCOPE’s work on medical devices, click here.