Regulations for the Prescription of Footwear as Medical Device

Orthopedic footwear is part of the category of medical devices used in the conservative treatment of foot and lower limbs pathomechanics. For the custom-made medical device the manufacturer has to perform the design based on the prescription of a duly qualified medical practitioner that sets the specific design characteristics of the device. Quality management standards in the field of medical devices govern the entire process (or parts thereof) from design and development to delivery and provide technical support for their implementation. In this respect, the prescription is constituted as an input, respectively an essential requirement of the design process and must be complete and unambiguous. This paper aims to analyse aspects of medical prescription as an essential requirement of the design and manufacturing process of custom-made orthopedic footwear.