Custom-made organ/bone anatomy model

Custom-made organ or bone anatomy models are 3D-printed replicas of a patient’s specific anatomy, designed to help surgeons visualize complex structures and plan procedures. These models are crafted from medical imaging data, such as CT or MRI scans, and are tailored to individual patients for pre-surgical planning and educational purposes.

These devices are typically regulated as custom-made products, often exempt from general conformity assessment due to their patient-specific nature. They are usually supplied directly to healthcare providers or surgeons, with compliance requirements varying by jurisdiction. Manufacturing and distribution follow strict quality controls to ensure accuracy and safety for surgical use.