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

EUDAMED is currently not mandatory. Further information can be found here: https://webgate.ec.europa.eu/eudamed/landing-page#/

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

This e-mail and any attachments transmitted may contain confidential and privileged information.  If you are not the intended recipient, please notify the sender immediately by returning the e-mail and permanently deleting what you have recieved. Any dissemination or use of this information by a third person without permission is prohibited and may be illegal.

Good Morning,

this is Mattia Russo from TSQ, a consultant company that offers several services. We’re offering an EU Representative service to an American manufacturer who want distribute a software as medical device (class IIa, only for professional users) in the Estonian market.

I would understand what the specific requirement is for:

-Language of Declaration of Conformity

-Fees to be paid for this kind of medical device

-The registration of the medical device inside the Estonian national data bank for medical device or Eudamed.

Thank you in advance.

Cordiali Saluti / Best Regards

Dott. Mattia Michele Russo, QARA Consultant Coordinator & Project Manager

ISO 13485 CERTIFIED 
MEDICAL DEVICE CONSULTING SERVICES

[email protected]

Via Leopardi,  Asti

Tel.  +39 0141 943426

[email protected]

www.tsquality.it

TS Q&E GmbH

Theilerstrasse 7
Zug (CH) 

[email protected]
www.tsquality.ch

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