Saatja: RA MSO </O=SOTSIAALMINISTEERIUM/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=72F3C63240224E00B8EFA069E66B5C58-RA>
Saaja:
[email protected]
Teema: Vs: Medical device registration fees in Estonia
Dear Alexander Börve,
Thank you for your enquiry.
There are no fees in Estonia for medical device manufacturer registration or for economic operators in general. However, fees do apply to certain activities, such as clinical investigations or performance studies and for issuing a certificate of free sale. More information on applicable fees for medical devices can be found on the State Agency of Medicines website <https://www.ravimiamet.ee/en/medical-devices/regulation-field-medical-devices-estonia#state-fees> .
The list of notified bodies under the MDR can be found in NANDO <https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notified-body-list?filter=legislationId:34,notificationStatusId:1> . In response to your question about whether there are any notified bodies in Estonia under the MDR, the answer is no. However, this does not affect the ability to place a medical device on the market, as notified bodies do not need to be located in the same country as the manufacturer.
In overall, the guidelines by the Medical Devices Coordination Group <https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en> should be followed. Any national additions and specifications can be found in the national Medical Devices Act <https://www.riigiteataja.ee/en/eli/510012025003/consolide> .
Do not hesitate to contact me should you require any additional information or have further questions.
Best regards,
Karl Kalev Türk
Specialist
Department of Medical Devices
State Agency of Medicines
[email protected] <mailto:
[email protected]>
1 Nooruse Street
50411 Tartu
Estonia
Phone: +372 737 4140
www.ravimiamet.ee <http://www.ravimiamet.ee/>
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Saatja: Alexander Börve <
[email protected] <mailto:
[email protected]> >
Saatmisaeg: neljapäev, 6. veebruar 2025 14:48
Adressaat: Ravimiamet <
[email protected] <mailto:
[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