
Questions & Answers on MDR “Custom-Made Devices”
What is a custom-made device? MDR Article 2 (3) defines a „custom-made device“ as any device that: is specifically made in accordance with a written prescription of any person authorized by national law by virtue of that person’s professional qualifications; which gives specific design characteristics provided under that person’s responsibility and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs. Examples can include devices made in accordance with a written prescription: Hand prosthesis An orthosis Orthopedic footwear Devices […]
READ MORE