Old devices (IVDR)

This is the IVDR counterpart of 'old devices'. It separates these devices from legacy IVDs, which continue to be placed on the market under IVDD certificates or declarations during the IVDR transition.

‘Old’ devices are those devices that were placed on the market or put into service before 26 May 2022 in accordance with the IVDD or the applicable national rules before the IVDD had become applicable and which are still on the market or in use after 26 May 2022.

MDCG 2022-8, Terminology used in this guidance