|Theme||Performance evaluation – COVID-19|
|Documents mentioned||Directive 98/79/EC
Annexes I & III
IMDRF/GRRP WG/N47 FINAL:2018
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.