Description
Date of UDI guidance: June 2025
The Unique Device Identification (UDI) system under the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) provides for enhanced traceability, combating counterfeiting and improving patient safety. A critical part of this system is the obligation to affix the UDI carrier on the device and/or packaging.
This practical guidance is a two-page document with examples of how UDI should look on labels of medical devices and IVDs.
Is this UDI Guidance for you?
This practical guidance is for you if you are searching for examples of UDIs and for the meaning of the codes within the UDIs.
How do you buy this product?
You can purchase our document directly on our website or with an invoice. Do you prefer paying with an invoice or have any questions on MDlaw, this product, or UDI in general? Contact us here or at mdlaw@obelis.net.
Do medical devices already need UDIs?
The deadlines to affix UDI under the MDR and IVDR are:
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- 26 May 2021: Implantable and Class III medical devices
- 26 May 2023: Class IIa and Class IIb medical devices, and Class D IVDs
- 26 May 2025: Class I medical devices, as well as Class B and Class C IVDs
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