Language requirements for COVID-19 antigen self-tests: Fimea's instructions for ensuring the availability of tests
There have been occasional availability issues with SARS-CoV-2 antigen self-tests as their demand has increased due to the update of the national testing strategy. Fimea has received many enquiries about the possibility of deviating from the legal language requirements for the instructions for using self-tests in order to bring self-tests intended for other markets to Finland.
The legislation requires that the labelling and instructions for using self-tests are written in Finnish and Swedish. A medical device intended for self-testing (so-called self-test) and its instructions for use are always a whole, the conformity of which is the sole responsibility of the manufacturer. The manufacturer's instructions for use in both national languages are an important part of the product: the instructions for using the self-test are a prerequisite for its safe use and for obtaining a reliable test result.
In order to ensure the availability of self-tests during the current epidemic situation, Fimea wishes to instruct actors with the application of language requirements. It is possible to import SARS-CoV-2 antigen self-tests that were originally not included the instructions for use in both Finnish and Swedish to Finland. The language requirements laid down in section 12 of the Medical Devices Act (629/2010) pertaining to EU directives on certain medical devices are met when both labelling and instructions for use are supplied with the product in both national languages.
Selling self-tests is allowed when:
- The product is CE marked, conforms to requirements and bears the identification number of the stated body.
- The self-test has been properly notified to Fimea. More information on Fimea's website: Registrations.
- The package contains labels and instructions for use in the national languages, or the Finnish and Swedish language versions of the labels and instructions for use that may be missing from the package are provided to the consumer fixed to the original packaging. This can be e.g. a sticker attached to the packaging or a zipper bag containing instructions for use together with each product.
- The attached labelling and instructions for use are approved by the manufacturer.
- The original labelling remains readable on the outside of the packaging.
- The manufacturer has approved of the procedure in writing.
The application of language requirements to self-tests is supervised by means of market surveillance.
Fimea's information package for rapid test distributors: Importers, distributors and would-be distributors of SARS-CoV2 (COVID-19) tests (pdf)
Information on registering medical devices on Fimea's website: Registrations
- Hanna Valo, Senior Inspector, tel. +358 29 522 3204
- Jari Knuuttila, Senior Inspector, tel. +358 29 522 3274
- Nelli Karhu, Senior Inspector, tel. + 358 29 522 3276
- Susanna Peltoniemi, Head of Section, tel. +358 29 522 3270
- E-mail addresses are email@example.com.