| Theme | Performance evaluation – COVID-19 |
| Target Audience | Manufacturers |
| Products concerned | IVD |
| 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.