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.
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:
- A UDI device identifier (‘UDI-DI’) specific to a device, providing access to the information laid down in Part B of Annex VI in Regulation (EU) 2017/745 (‘MDR’) and Regulation (EU) 2017/746 (‘IVDR’)
- A UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable the packaged devices, as specified in Part C of Annex VI in Regulation (EU) 2017/745 (‘MDR’) and Regulation (EU) 2017/746 (‘IVDR’).
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