Kiri

Dear Carly,

Thank you for your inquiry.

There is a distribution notification requirement in Estonia is based on Estonian Medical Devices Act § 26 (4) (https://www.riigiteataja.ee/en/eli/ee/524012023001/consolide/current) which says:

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 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 Health Board thereof within 10 days after distribution of the relevant medical device for the first time.

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. 

If there is a need for an account, please let me know.

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“.

Please familiarize yourself comprehensively with the national Medical Devices Act so that you are up to date with the national requirements.

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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Hello,

My name is Carly Desmond.  I am the Director of Regulatory Affairs for ClaroNav Inc.

ClaroNav manufactures a Dental Navigation system called Navident, which is CE-marked in accordance with the MDD, and following the transitional arrangements of the EU MDR.

We have a interested customer in Estonia and would like to confirm that we are meeting all requirements to sell in the country.

In addition to holding a valid EC Certificate, my understanding is that we must submit a notification to TEHIK within 10 days of distribution.  Are we able to submit the notification directly? Are there any other requirements?

Best regards,

Carly Desmond

Director of Regulatory Affairs

Phone: +1-437-339-6856

E-mail:  [email protected] 

www.claronav.com