Systemic absorption

In MDR classification, whether a substance or its metabolites are systemically absorbed affects the class under rule 21 and is relevant to other rules. It is a central question for substance-based devices at the borderline with medicines.

Systemic absorption: The process by which substances or their metabolites enter the body (e.g. by crossing mucous membranes) and are distributed into the body via the blood and/or lymphatic system.

MDCG 2021-24 Rev.1, Section 3.1, Basic terms and definitions (Other terms)