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