Küsimused

Dear Evgeni Vainstein,

Thank you for your enquiry.

The requirements for notifications associated with distribution of medical devices are set out in Estonian Medical Devices Act, § 26 (4) most specifically:

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 (OJ L 189, 20.07.1990, p 17–36) or Council Directive 93/42/EEC concerning medical devices (OJ L 169, 12.07.1993, p 1–43) 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.

But please do familiarize yourself with other national requirements as well in the MDA.

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 persons full name and e-mail. Please note that accounts in the database are personal (not for the company).

Documents submitted with the notifications of medical devices are mostly as follows: Declaration of conformity, EC certificate(s), instruction for use and copy of the labelling or packaging. But have a look at the short guide for using the EMDDB under section Forms when on the ENG page of the database for additional information.

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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Dear Sir/Madam,

Our company Inomedis Nordic OU is distributing medical devices(not farmaceutical), only EBD within Baltic States.

I would like to clarify if we supposed to notify Ravimiamet about that or not? If yes, please be so kind to provide us link to the notification form.

Thank you in advance,