Embryo / foetus

This definition matters for IVDs used in prenatal testing, which the IVDR classification rules treat as higher risk. Because maternal samples containing embryonic or foetal material are included, tests run on maternal blood can count as tests on the embryo or foetus.

an unborn refers to stages in human development after zygote formation. A zygote is considered an embryo in particular from the period of conception to approximately the eighth week, and considered a foetus following this period until birth. Samples from the embryo or foetus include samples from the embryonic/foetal membranes, fluids and excretions, the umbilical cord, and maternal samples (e.g. blood) containing embryonic/foetal material to be examined.

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