Kiri

Dear Miki,

Thank you for your enquiry.

Indeed, there is a mandatory distribution notification requirement in Estonian and it is based on Medical Devices Act § 26 (3¹) (https://www.riigiteataja.ee/en/eli/ee/524052016001/consolide/current) which says:

Any person who distributes for the first time in Estonia or puts into professional service a class II a, II b or III medical device or an active implantable medical device shall notify the Health Board thereof within ten days after distribution for the first time or putting into professional service of the device.

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

The notification is free of charge. We recommend companies to find an Estonian citizen who can log into the database (by mobile-ID or by ID-card) and who will register their represented company’s medical devices into our database. It is because some of the information is needed in Estonian.

If needed 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.

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

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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