A 'custom-made device’ is made according to a written instruction by any person authorised by national law through their professional qualifications. This leads to specific design characteristics unique to that device. Such a device is for the sole use of a particular patient and exclusively to meet their individual conditions and needs.
Mass-produced devices that are adapted to meet the specific requirements of any professional user are not considered custom-made devices. This includes adapted versions of devices that are mass-produced through industrial manufacturing according to written instructions by an authorised person.
- See MDCG 2021-3 - Questions and Answers on Custom-made devices & considerations on adaptable medical devices and Patient-matched medical devices
- See MDR Article 52 (8) and Annex XIII - procedure for custom-made devices
