On 21 January 2021, Member States unanimously agreed on a Council recommendation setting a common framework for the use of rapid antigen tests and the mutual recognition of COVID-19 test results across the EU.The products need to meet the following requirements:

(a) Carry CE marking;

(b) Meet the minimum performance requirements of ≥ 90% sensitivity and ≥ 97% specificity; and

(c) Have been validated by at least one Member State as being appropriate for their use in the context of COVID-19, providing details on the methodology and results of such studies, such as the sample type used for validation, the setting in which the use of the test was assessed, and whether any difficulties occurred as regards the required sensitivity criteria or other performance elements.

he Health Security Committee agrees that, for rapid antigen test results to be mutually recognized, at least three Member States should be using a rapid antigen tests in practice.

On 21 January 2021, Member States unanimously agreed on a Council recommendation setting a common framework for the use of rapid antigen tests and the mutual recognition of COVID-19 test results across the EU.The products need to meet the following requirements:

(a) Carry CE marking;

(b) Meet the minimum performance requirements of ≥ 90% sensitivity and ≥ 97% specificity; and

(c) Have been validated by at least one Member State as being appropriate for their use in the context of COVID-19, providing details on the methodology and results of such studies, such as the sample type used for validation, the setting in which the use of the test was assessed, and whether any difficulties occurred as regards the required sensitivity criteria or other performance elements.

he Health Security Committee agrees that, for rapid antigen test results to be mutually recognized, at least three Member States should be using a rapid antigen tests in practice.