Custom-made device

Custom-made devices follow Annex XIII of the MDR rather than the normal certification route, with a statement instead of CE marking. Mass-produced devices that are adapted or patient-matched are not custom-made, even if each one is different.

‘custom-made device’ means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs. However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices;

EU MDR, Article 2(3)