Kiri

Dear Barbara,

Thank you for your inquiry.

I would like to remind you the distribution notification obligation as stated in the Estonian Medical Device Act § 26 (4):

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 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.

As written in the bold, this requirement is within 10 days after distribution, not before. Therefore, the answer to your question is no – you do not have to wait for the confirmation.

Distribution notifications can be carried out by all companies and firms regardless of their location. In case the company representative is located outside of Estonia and unable to log into the database via Estonian identity authentication options, the representatives can access the database by using a username and password. To obtain an account, they should write to us with such a request.

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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Dear Sir/Madam,

I am contacting you because I have a question in regards of the notification process in Estonia.

When the necessary documentation to add an already CE mark product to the Estonian database has been submitted, it is necessary to wait for confirmation that the product has been added in order to commercialize it in Estonia? Is it a notification with/without approval?

Sometime the confirmation of adding the CE mark product to the database can be delayed due to the need to clarify some aspects or provide additional documentation requested and the completion of the process can be postponed in a certain time.

Also, I would like to know if the notifications can only be made by local companies and distributors or  is it possible for companies that do not have fiscal address in Estonia because to perform notification?

I thank you in advance for your kind support!

Best regards,

/Barbara Björkbom

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