Transmissible agent

Under the IVDR, tests that detect transmissible agents in donated blood, tissues or organs, or agents of life-threatening transmissible diseases, are among the highest-risk IVDs. MDCG 2020-16 uses the term in its classification guidance.

means a biological substance or entity capable of causing disease or infection in individuals through individual to individual, animal to individual, or other modes of contact.

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