Regulatory basis - MDR Art. 28–29 / IVDR Art. 25–26. Manufacturers must register all devices placed on the EU market in EUDAMED, linked to the Basic UDI-DI. Registration is a prerequisite for placing the device on the market within the applicable class timelines.
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.
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.
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.
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.