Fimea reminds importers and distributors of Covid-19 at-home tests of the special requirements related to the tests
An at-home test is a test specifically intended by the manufacturer for layman use that has been demonstrated to be safe and effective in this specific use. The at-home tests sold in Finland must always have package labelling and instructions for use in Finnish and Swedish provided by the manufacturer.
In addition, tests intended as at-home tests (‘self-tests’) must always have an EC certificate issued by a Notified body as well as a Declaration of Conformity, which together demonstrate that the test is suitable for layman use. In this case, the code of the Notified body that evaluated the product is also shown next to the product’s CE marking (four-digit code, CE XXXX). A register notification of imports into Finland and resale to professionals of at-home tests must be filed with Fimea.
The purpose and user group of the test specified by the manufacturer should be clearly indicated in the marketing of all Covid-19 tests. In all marketing of tests intended for professionals, care must be taken to ensure that the marketing is targeted exclusively at healthcare professionals. Rapid tests intended for professionals should not be marketed to consumers for at-home use.
The Finnish Institute for Health and Welfare (THL) has prepared instructions for at-home testing. The instructions explain what to do with negative or positive test results obtained from at-home tests. Importers and retailers of at-home tests are strongly recommended to provide their customers with information about THL's additional instructions upon purchase of the at-home test. The information provided to the customer does not have to include THL’s instructions in their entirety; it is sufficient that the customer is referred to the up-to-date national instructions. The information content of the instructions must be consistent with the information provided by the manufacturer. The provision of the instructions to customers can be carried out by means of a hardcopy or electronic announcement given in connection with the supply of the product.
- Hanna Valo, Senior Inspector, tel. +358 29 522 3204
- Nelli Karhu, Senior Inspector, tel. + 358 29 522 3276
- The e-mail address format is email@example.com.