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:
- 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’).
Our experts at Med-Di-Dia will provide you with complete guidance and support.
Contact us for a Free consultation
Call: +353 (0)91-704804
Email: mdd@mddltd.com
