End of the validation procedure for SARS-CoV-2 antigen self-tests
January 27, 2023
The validation procedure for SARS-CoV-2 antigen self-tests with a CE-marking ceased to apply since 23 January 2023. The associated list of recommended SARS-CoV-2 antigen self-tests with a CE-marking is therefore no longer available.
This list with recommended SARS-CoV-2 antigen self-tests with a CE-marking was published according to Article 2 of the Royal Decree of May 11, 2021. Article 2 has since been amended by the Royal Decree of June 24, 2021, thereby removing the obligation for a SARS-CoV-2 antigen self-test to appear on this list.
Obligations in order to make self-tests available on Belgian territory
As a reminder, manufacturers have to provide all information accompanying the self-tests in the three national languages (FR, DE, NL).
Note that manufacturers, importers and distributors are still obliged to register the SARS-CoV-2 antigen self-tests that they make available in Belgium by using the online applications of the FAMHP.
For all questions related to reimbursement
NIHDI website: FR - NL
NIHDI contact: FR - NL