Basic UDI-DI, UDI-DI – general information

New requirements for medical devices, ie Regulation 2017/745 with changes to EU version of illegal compliance and certificates. In addition to identifying the potential manufacturer and the risk associated with the search for this item, the requirement to include the Basic UDI-DI code, i.e. the main model identifier of the medical device. Detailed information on the UDI (Unique Identification Code) system – product specific identification is included in Annex VI, Part C of the MDR. The Basic UDI-DI code is the engine identifier of the product. It is the DI code assigned at the level of the product use unit. This is the main key that introduces information into the UDI database and is the topic indicated in the relevant EU certificates and declarations of conformity. Prior to placing on the market a device other than a custom-made device, the manufacturer of the device shall provide the Basic UDI-DI code as set out in Annex VI, Part C, and enter it into the UDI database along with other basic data referred to in Annex VI, Part B, invariably the product. Basic UDI-DI is a mandatory attribute in the EUDAMED data table. It is used for medical devices and is tried from packaging or labels. In other words, the Basic UDI-DI code identifies the product model itself in a unique way, while the UDI-DI code identifies the commercial avoc in the supply chain.
The Basic UDI-DI code is generated by the GS1 Society which was designated by the Technical Platform as the UDI issuing organization in June 2019. Mail buy from May 26, 2021, all medical devices from the risk class must be assigned the Basic UDI-DI code. For UDI-DI codes, the identification in the commitment period chain depends on the risk class and so:
Risk class III finished products – May 26, 2021
Devices of risk class IIa and IIb – 2023
I risk class devices – 2025
If you have any questions about the UDI system, please do not hesitate to contact us.

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