Newborn

The term is used in MDCG 2020-16 on IVD classification, where screening newborns for congenital disorders can place a test in a higher class because a missed diagnosis may lead to life-threatening situations or severe disability.

a newborn, or neonate, refers to an infant in the first 28 days after birth.

MDCG 2020-16 Rev.5, Section 2, Definitions