Read this guys THRM obtained a CE, isn't it? Using white label or something like that!
Applying for a temporary exemption
Currently rapid tests are formally classified as medical devices and may only be used under the medical responsibility of a doctor. They cannot simply be marketed as self-tests. However, starting this week, manufacturers and distributors of rapid antigen tests will be able to apply for an exemption to market their product as a self-test. Manufacturers have to meet certain requirements to obtain such an exemption. For instance, the product must already bear a CE marking for professional use as a rapid antigen test and must have been validated for use as a self-test. Exemptions can be granted within a week. Please refer to the ‘Procedure to obtain exemption for rapid antigen test for use as self-test’ for the complete list of requirements and further information. Granted exemptions will initially be valid until 31 December 2021.
The ministry has asked a group of experts to come up with a practical solution by the end of this month to clear the way for supervised self-testing using antigen tests for businesses and educational institutions.