Devices

MDCG 2023-3 uses this collective word so that each vigilance answer covers the whole range of products under the MDR and IVDR. When the guidance says 'devices', the statement also applies to IVDs and Annex XVI products unless the text says otherwise.

Unless quoted directly from the legal text or otherwise specified, the term ‘devices’ will be understood to include medical devices, accessories for medical devices, products listed in Annex XVI of the MDR, in vitro diagnostic medical devices and accessories for in vitro medical devices.

MDCG 2023-3 Rev.2, Introduction