Additive manufacturing, a technology used to manufacture parts layer-by-layer from a 3D digital model, offers an effective solution. Indeed, the key advantage of this technology, in the medical sector, is to produce on demand (without the need of a large inventory of different sizes or sterile storage) customised medical devices for specialities such as orthopaedic, spinal, cranial, maxillo-facial, and dental surgery, and to provide grafts that promote bone growth which match the patient’s anatomy. The overall objective of this project is to provide a comprehensive basis to enable the safe and cost efficient use of additive manufacturing (AM) products within the medical sector. Therefore, within this project AM off-the-shelf medical devices as well as patient specific guides (PSG) and patient specific implants (PSI) manufactured from patient X-ray Computed Tomography (XCT) image data sets or computer aided design (CAD) will be qualified. This will guarantee their reliability to notified bodies and facilitate acceptance of this technology, which has proven clinical advantages in the medical sector.