- 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