Patient-matched device

Under the EU MDR, patient-matched devices are not custom-made devices, because they are made in a validated, reproducible process within a design envelope. They go through the usual conformity assessment rather than the custom-made route.

A patient-matched device is defined as a medical device that meets the following requirements: • it is matched to a patient’s anatomy within a specified design envelope using techniques such as scaling of the device based on anatomic references, or by using the full anatomic features from patient imaging; and • it is typically produced in a batch through a process that is capable of being validated and reproduced; and • it is designed and produced under the responsibility of a manufacturer even though the design may be developed in consultation with an authorized healthcare professional.

MDCG 2021-3, Question 1, Note 2 (as defined by IMDRF)