Import to Finland of at-home tests

If the product is intended for at-home use, this shall be indicated in the instructions for use, in the DoC and in the separate certificate issued by the notified body.
In the case of an IVD device for self-testing (e.g., a pregnancy test and other at-home rapid tests, blood glucose strips) an evaluation by an external inspection body (notified body) is always required as well. 

An IVD device (e.g., a rapid test) intended for professional use may not be marketed to consumers for at-home use. Marketing may not give the impression that, for example, a product intended for professional use would be suitable for layman use, or that the product would have been proven to be safe and functional in at-home use. 
 
IVD devices for self-testing (at-home tests) imported to Finland must be reported to Fimea’s medical device register.   

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Importers, distributors and would-be distributors of SARS-CoV2 (Covid-19) tests