Deadlines
VIDEO: UDI registration of devices in EUDAMED
VIDEO: From which date do you assign a UDI?
The obligation for UDI assignment: it applies as from the date of application of the two new Regulations, i.e. 26 May 2021 for medical devices (MDR) and 26 May 2022 for in vitro diagnostic medical devices (IVDR).
The obligation for submission of UDI data in the EUDAMED database: this obligation applies 24 months after EUDAMED has become fully functional.
The obligation for placing the UDI carrier applies according to the following timelines:
MDR Placing UDI-carriers on the labels of devices (MDR Article 123(3)(f), Article 27(4)):
Implantable and class III devices: 26 May 2021
Class IIa and class IIb devices: 26 May 2023
Class I devices: 26 May 2025
Direct marking of the reusable devices (MDR Article 123(3)(g), Article 27(4)):
Implantable and class III devices: 26 May 2023
Class IIa and class IIb devices: 26 May 2025
Class I devices: 26 May 2027
IVDR Placing UDI-carriers on the labels of devices (IVDR Article 113(3)(e), Article 24(4)):
Class D IVDs: 26 May 2023
Class C and B IVDs: 26 May 2025
Class A IVDs: 26 May 2027