Küsimused

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.

The list of notified bodies under the MDR can be found in NANDO. 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 should be followed. Any national additions and specifications can be found in the national Medical Devices Act.

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]

1 Nooruse Street
50411 Tartu
Estonia
Phone: +372 737 4140

www.ravimiamet.ee

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