A custom-made device is a device specifically made in accordance with a written prescription (order) of a professionally qualified person who is authorised by national law to issue such an order. This person is solely responsible for determining the exact design and characteristics of the device. The custom-made device is intended for the sole use of an individual patient to meet their individual health conditions and special needs. The legal definition of custom-made devices can be found in Chapter 1, Article 2, Paragraph 3, MDR.
An example of a custom-made device is a custom-made dental prosthesis that is made from raw materials or semi-finished products for the specific anatomical conditions of an individual person. In this case, the qualified person would be a dentist.
Another example is a custom-made hand orthosis, which may be made from a modular system.
Mass-produced products that are adapted to the needs of patients without significant changes are not defined as custom-made.
