Old devices

Old devices are not legacy devices: they were placed on the market before the MDR applied, and individual units can continue to be made available. Serious incidents and field safety corrective actions involving them are still reported.

Old devices are those devices that were placed on the market before 26 May 2021 in accordance with the AIMDD or the MDD or in accordance with the applicable rules before the Directives had entered into force.

MDCG 2022-21, Section 1.2, Terminology

‘Old’ devices are those devices that were placed on the market or put into service before 26 May 2021 in accordance with the AIMDD or the MDD or in accordance with the applicable rules before the Directives had entered into force.

MDCG 2021-25 Rev.1, Section 2.2, Terminology used in this guidance

‘Old’ devices: devices placed on the market according to the medical devices Directives or the in vitro diagnostic medical devices Directive before the date of application of the MDR and IVDR or placed on the market before the Directives entered into force.

MDCG 2021-13 Rev.1, Terminology

MDCG 2022-21 counts only devices placed on the market before 26 May 2021, while MDCG 2021-25 adds devices put into service before that date. MDCG 2021-13 refers to the date of application of the MDR and IVDR and also covers devices under the IVD Directive.