The IMDRF defines personalized medical devices, including Custom-made, patient-matched, and adaptable devices according to IMDRF/PMD WG/N49 (2018). Within this document, the scope of custom-made has been narrowed from the previous definition of custom-made (pre-2018), with patient-matched now being used to describe many devices that were previously considered custom-made. The GMDN does not (yet) refer to patient-matched devices. Therefore, equivalent patient-matched AND custom-made devices should be assigned to the same GMDN Term describing a custom-made device.
For example, the most appropriate GMDN Term for a patient-matched orthotic insole might be ‘GMDN 62870 – Orthotic insole, custom-made’. In this instance ‘custom-made’ would simply mean a device manufactured to meet an individual’s specific requirements (patient-specific) and the GMDN Term description could cover both patient-matched and custom-made orthotic insoles.