Target patient group

MDCG 2023-1 uses the term for devices made and used within health institutions, where the institution has to justify that no equivalent device on the market meets the needs of this group.

In this context, the target patient group should be understood as a group of patients who have in common the same disease, condition or characteristics, and who could benefit from using the device.

MDCG 2023-1, Section 3.6.1, Target patient group’s specific needs