Member Info for McMakhlas

According to the European Centre for Disease Prevention and Control (15 April 2020) (3) and FIND (2), 10 COVID- 19 antigen detection RDTs and over 90 COVID-19 antibody RDTs are Conformité Européenne (CE)-marked. However, they are CE-marked according to the “In Vitro Diagnostic Device Regulations” Directive 98/79/EC and not by the new Directive EU 2017/746 (which is more stringent and will be effective from 2022 onwards). According to the “old” 98/79/EC, manufacturers can obtain CE-mark by self-declaration and performance evaluation is therefore limited.
Title: COVID-19 Rapid Diagnostic Tests: use in low resource settings First authors: Jan Jacobs
Last Update: 30/04/2020 (v1.3)

https://www.itg.be/Files/docs/COVID-19-Rapid-Diagnostic-Tests.pdf