Küsimused

Dear Sir or Madam,

The requirements for notification on distribution of medical devices in Estonia are briefly covered here:

https://ravimiamet.ee/en/medical-devices/medical-devices/regulation-field-medical-devices-estonia

Notification about distribution can be completed through our national Medical Devices and Appliances Database (EMDDB) https://msa.sm.ee/ and it is free of charge.

For actors outside of Estonia we can make an account manually, so it is possible to log into the database with username and password. For creating an account we need a contact persons full name and e-mail. Please note that accounts in the database are personal (not for the company).

I most cases, documents expected with the notifications of distribution of medical devices are the following: Declaration of conformity, EC certificate, instruction for use (original and in Estonian if required) and copy of the labelling or packaging.

Also, have a look at the section on language requirements in Estonia:

https://ravimiamet.ee/en/medical-devices/medical-devices/labelling-language-requirements

Let us know if you have further questions or require an account for EMDDB.

Best regards,

Piret Põiklik
Head of Department

Department of Medical Devices
State Agency of Medicines

[email protected]
+372 5853 3610

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

www.ravimiamet.ee

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