Regulatory pathways for market access of 3D Printed devices vary depending on the country/region. Recent examples show deep involvement of regulators like the FDA and TGA Australia in setting the stage. In the EU, this is not so clear, and often, 3D printing and custom-made are considered as one and the same. The change towards the new MDR will further impact this situation. Having clear and unambiguous pathways is crucial for the access of 3D printed devices to hospitals and reimbursement. As a market leader in medical 3D printing, Materialise is approaching these challenges and is looking into creating a network with other players in the same context.