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Medical Devices - UDI


With the launch and adoption of the Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) throughout the European Union Market, it is important to understand the basic terminology. The economic operators have a vital role in managing the smooth implementation of the MDR and IVDR.


Understanding UDI

UDI stands for Unique Device Identification. This system was introduced via the EU MDR updates. It is a series of numeric/ alphanumeric characters which are created and accepted globally using device identification and coding standards. This alphanumeric series allows explicit identification for a medical device placed on the market. The UDI may include information from the lot or serial number and should be acceptable globally.


UDI comprises of UDI-DI and UDI-PI

The production of a UDI comprises the following:

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