Kiri

Dear Liga

Thank you for your inquiry. I hope I understood you correctly that your question concerns distribution of in vitro medical devices in Estonia.

Indeed, there is a distribution notification obligation in Estonia and it is based on 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.

Notification about distribution can be completed through our national Medical Devices and Appliances Database, https://msa.sm.ee/eng 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 the 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 that need to be supplied depend on which class of devices you plan to distribute. For class A in vitro medical devices they are the following: Declaration of Conformity (as described in annex IV of IVDR), instructions for use and copy of the labelling or packaging of the device. For class B and C devices you also need to present the EC Certificate of Quality Management System. For class D devices we need two EC Certificates.

A few explanatory words about instructions for use as well. If the devices that you plan to distribute are meant to be used by lay users, you have to provide the IFU in both English and Estonian on the application (taking note of that these are of the same version). If, however, the devices are for professional use only (which has to be clearly stated in the documentation you provide), IFU can be provided only in English if the end user has agreed to it.

Also, please use a short guide for using the Estonian Medical Device Database that can be found on database homepage under „Forms“. It is a step-by-step guide on how to carry out the notification process successfully in the database.

Please do not hesitate to contact me for further information or with any questions.

Best regards

Janne Aule

Chief Specialist

Department of Medical Devices

+37258668664

[email protected]

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Good afternoon! 

My name is Līga Meldere, I'm working in a company that manufactures medical devices and we are located in Latvia. 

We would like to register In - vitro diagnostics kits in Estonia and I would like to know what kind of documentation we need to do that.

Is there any website to that and is there any registration fee? 

Could you please describe the process itself?

I would really appreciate your support and help!