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Saatja: Keiu Põderson </O=SOTSIAALMINISTEERIUM/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=USER155B6E28> Saaja: RA MSO Teema: Ed: Medical device registration fees in Estonia Saatja: Alexander Börve <[email protected]> Saatmisaeg: neljapäev, 6. veebruar 2025 14:48 Adressaat: Ravimiamet <[email protected]> Teema: Medical device registration fees in Estonia Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Hi We are a Swedish medical device as a software manufacturer. We are looking to set up a new EU entity and we want to look into Estonia. How much is the annual fee for registration of our medical device as a software MDR class 2a in Estonia? Are there any other fees? Do you have a notify body in Estonia? This is our current device: https://ec.europa.eu/tools/eudamed/eudamed#/screen/search-device/9c9e6772-7e06-4334-8699-c02f8e3960a3 Cheers Alexander Börve CEO