What is the UDI-DI deadline?

• 445
• admin
• 2023-3-9

UDI obligations: apply the date of implementation of the two new regulations, namely medical devices May 26, 2021, and in vitro diagnostic devices May 26, 2022.

· Obligation to submit UDI data in the EUDAMED database: This obligation applies for 24 months after EUDAMED is fully operational (Eudamed extension);

· The obligation of the carrier to place the UDI applies according to the following schedule:

The MDR places the UDI carrier on the product label (MDR Article 123, paragraph 3 letter f, Article 27, paragraph 4) :

· Implantable devices and Class III devices May 26, 2021

Class IIa and Class IIb products May 26, 2023

· Class I products May 26, 2025

Direct labelling of reusable products (MDR Article 123, paragraph 3, letter g), Article 27, paragraph 4) :

· Implantable devices and Class III devices May 26, 2023

Class IIa and Class IIb products May 26, 2025

· Class I products May 26, 2027

IVDR appends the UDI carrier to the product label (IVDR Article 113 (3) letter e, Article 24 (4)) :

· Class D IVD May 26, 2023

Class C and Class B IVD May 26, 2025

· Class A in vitro diagnostic equipment May 26, 2027



The requirements for implementing and creating a UDI are registered in one of the issuing entities (currently GS1, IFA, HIBCC, ICCBBA).