A custom-made medical device is a device manufactured based on a written prescription of a health care professional (HCP) and with specific features or design characteristics intended for a specific patient to treat the individual condition. So, a custom-made device can be a modified regular device to meet the patient’s individual condition. For example, a manufacturer produces regular tibia implants to restore broken tibiae. The regular design holds locking holes in proximal and distal positions. The patient to be treated, however, needs additional locking holes as the bone is fractured in a specific way and only by the help of the additional locking holes, the tibia can be restored. These locking holes, their position and dimensions are stated by the HCP and are in the responsibility of the HCP.
Such a device would most probably be considered a custom-made device.