Küsimused

Dear Wessel Hornman,

Thank you for your enquiry.

From your letter, we understand that you intend to distribute your manufactured medical devices in Estonia. In the case of distributing a higher risk class medical device in Estonia, there is a distribution notification requirement which is based on Medical Device Act § 26 (4):

Every undertaking who distributes on the market of Estonia a system or procedure pack of medical devices according to Article 22 of Regulation (EU) 2017/745 of the European Parliament and of the Council or a class IIa, IIb or III medical device classified according to Regulation (EU) 2017/745 of the European Parliament and of the Council or Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices or Council Directive 93/42/EEC concerning medical devices or class B, C or D in vitro diagnostic medical devices classified according to Annex VIII of Regulation (EU) 2017/746 of the European Parliament and of the Council, shall notify the State Agency of Medicines thereof within 10 days after distribution of the relevant medical device for the first time. 

Notification about distribution can be completed through our national Medical Devices and Appliances Database (EMDDB) https://msa.sm.ee/ and 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 person’s full name and an e-mail.

Therefore, should the EMDDB account be registered under your name? If not, please direct the responsible person in your organisation to contact us with a request for the account in the database.

Documents with the notifications of medical devices are following: Declaration of conformity, EC certificate, instruction for use and copy of the labelling or packaging. For more detailed information about the distribution process in general, please refer to the short guide available under „Forms“ in the database.

We also recommend that you familiarise yourself with the national legislation, Medical Devices Act, as it regulates the language requirements for medical devices as well as the aforementioned distribution requirement.

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