Kiri

Dear Pernilla,

Thank you for your letter.

Your inquiry does not specify the risk class of the medical device in question, but there is a distribution notification requirement for certain risk class devices in Estonia and it 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“.

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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Good Morning,

Ottobock Scandinavia AB, which is a legal company registered in Sweden, are planning to start market a medical device from the brand Exopulse in Estonia.

Before doing do, where do we register this with the authorities and information do you need?

The product is CE-marked and have the necessary technical documentation.

I have looked into your website but not been able to find a registration form,

Thank you in advance,

Hälsningar/Kind Regards

Pernilla Fridh

QEHS & RA Specialist

Ottobock

Greater Nordic Region

Box 4041 | SE-169 04 Solna | Barks väg 7 | Sweden

Phone: +46 (0)722 023456

[email protected] | ottobock.se