Kiri

Dear Mathilde,

Thank you for your inquiry. Unfortunately, we have not received your previous email, and as a result, it has remained unanswered.

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“.

The national distribution notification is separate from the EUDAMED registrations, and it remains in place even when EUDAMED is fully functional.

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] 

This e-mail is confidential and meant for use by the person named in the letterhead. Any use in any way or copying of it by a person not marked as the addressee thereof is prohibited. If you have got this e-mail by mistake, please notify of it the sender without delay and delete the received e-mail together with all its attachments.

Good day,

I hope you are well today,

I would like to remind you about this subject; indeed, we are still waiting for your answer in order to register your products in your country.  

I thank you in advance.

Best regards,

Mathilde Mirotta  

Good Day,

My name is Mathilde Mirotta and I write to you from South Africa, Southern Implants.

Southern Implants manufactures and distributes dental and facial implants worldwide, and we have been doing so, successfully for 35 years.

I work on medical device registration for Southern Implants.

I would like to know the medical device registration process for your country.

Where do I need to register my medical devices to be registered by the Ministry of Health? Or if I register my products on EUDAMED, is that enough ? 

I thank you in advance.

Best regards,

Mathilde Mirotta