Theme Performance evaluation – COVID-19
Target Audience Manufacturers
Products concerned IVD
Documents mentioned Directive 98/79/EC

Annexes I & III



This new MDCG guide focuses on the state of the art of COVID-19 rapid antibody tests.

It first describes the expected performance of COVID tests according to the requirements of Directive 98/79/EC. It then links the assessment of these performances to the state of the art.