Hamburg, 17th March 2021, Dr. Peter Wirthschaft
The Medical Device Coordination Group (MDCG) provided a guidance for manufacturers of rapid COVID-19 antibody tests, specifying minimum performance criteria and design considerations for IVD medical devices intended for the detection of antibodies against SARS-CoV-2.
The Directive 98/79/EC requires manufacturers to take into account the generally acknowledge state of the art. To help manufacturers fulfilling this legal requirement, „the considerations presented in this guidance are intended to establish particular elements on the current state of the art for COVID-19 rapid antibody tests. It will also assist with understanding what the current state of the art is.“