UDI overview & structure
Both MDR 2017/745 and IVDR 2017/746. UDI requirements are set out primarily in MDR Art. 27 / IVDR Art. 24 and MDR Annex VI / IVDR Annex VI.
UDI-DI & UDI-PI explained
Regulatory basis - MDR Annex VI Part B and C and IVDR Annex VI Part B and C. The UDI consists of a Device Identifier (UDI-DI) and a Production Identifier (UDI-PI). Understanding the distinction is fundamental to UDI system compliance.
EUDAMED UDI registration
Regulatory basis - MDR Art. 27(3)–(4) and Art. 28–29 / IVDR Art. 24(3)–(4) and Art. 25–26. Manufacturers must register their devices in EUDAMED using the UDI as the primary identifier before placing devices on the EU market.
UDI labelling requirements
Regulatory basis - MDR Art. 27(4)–(6) / IVDR Art. 24(4)–(6) and MDR Annex VI Part C / IVDR Annex VI Part C. These provisions specify where and how the UDI carrier must appear on device labelling.