Vastuskiri

Dear Rasa,

Thank you for your inquiry.

The distribution notification can be done through Estonian Medical Device Database (EMDDB, https://msa.sm.ee/).

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 person’s full name, e-mail and the position in the company. 

Therefore, does the account go to your name?

Documents with the notifications of medical devices are following: Declaration of conformity, EC certificate, instruction for use in English, instruction for use in Estonian and copy of the labelling or packaging.

Also, please use a short guide for using the Estonian Medical Device Database that can be found on database homepage under „Forms“.

NB! Please note that the access to the database is limited to users outside of Estonia.

In case of this, please contact with [email protected] with an request to access to the database and your IP address. They will white-list your IP and you should have an access to the database.

This is a temporary restriction for security reasons which hopefully will be removed in near future.

Please do not hesitate to contact me for further information or any questions.

Best regards,

Karl Kalev Türk

Chief Specialist

Department of Medical Devices

Phone +372 5648 5663

[email protected] | [email protected] 

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Dears,

I am writing to request the creation of an account for our company, UAB Baltics Medical to login in the EMDDB.  We would like to do the notification of a medical device IIA, IIB, III. Unfortunately, we do not possess an Estonian ID-card, and therefore, we are seeking your assistance to proceed.

Thank you.

Rasa Pudžaitienė

Public Procurement Specialist

E: [email protected]

M: +37065767869

W: www.balticsmedical.com