Registration of Old and Custom-Made Devices (OCM)

According to the Medical Devices legislation, old and custom-made devices (OCM) are not to be registered in the UDI/Devices module but are to be referenced in Vigilance dossiers.

Old Device:

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.

Custom-made Device:

Any device specifically made in accordance with a written prescription of any person authorized by national law by virtue of that person’s professional qualifications which gives, under that person’s responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.

Link for the EUDAMED (PG) user guide on old and custom-made devices (OCM)