The transitional period for the IVDR has been extended!

On July 9, 2024, the European Parliament and the Council issued a regulation that amends both the MDR and IVDR.
The most important changes:

• Extension of the IVDR transitional period for certain devices that meet specific conditions.
• Facilitation of the gradual implementation of EUDAMED.
• Introduction of a requirement for manufacturers to provide information if the supply of certain devices is interrupted or discontinued.

The end of the IVDR transitional period has been modified as follows according to the new regulation:

• For class D devices: December 31, 2027.
• For class C devices: December 31, 2028.
• For class B and sterile class A devices: December 31, 2029. The regulation entered into force on the day it was published in the Official Journal, except for the manufacturers’ notification obligation, which applies from January 10, 2025.

The regulation can be found here: (EU) 2024/1860.

Source: Saasco Kft.