Can I use the inne minilab for contraception?

Our inne minilab has been certified as a diagnostic device (IVDD) since 2019.

This certificate will remain valid for the new evolution of the inne strip and minilab as we can show that the incremental changes do not negatively affect the performance.

Contraception is considered an entirely new use, and a significant change. This is not covered by inne’s existing certificate, and the results from our Clinical Study must be confirmed by the relevant notifying body as part of this process. We have applied for Contraception under the new EU regulations (IVDR), but due to delays with our notifying body we do not know when we will be able to be assessed for certification for Contraception.
You can find more information about our certification and insights into our clinical study here.