Vastuskiri

Dear Jae-Yeon,

You are correct that in order to distribute class IIa medical devices in Estonia, you need to notify us through the Estonian Medical Devices and Appliances Database (EMDDB). This can be done free of charge. For actors outside of Estonia we can make an account manually, so it is possible to log into the database with a username and password. For creating the account we need a contact person’s full name, e-mail and the position in the company.  Once you supply us with these details, I can make the account for you.

Documents that need to be supplied with the notifications of class IIa medical devices are following: Declaration of conformity (as described in annex IV of MDR), EU Certificate supplied by a notified body, instructions for use (in English and Estonian if the device is meant for lay users, English only if it’s for professional users who have agreed to receive IFU in English prior to delivery) and copy of the labelling or packaging of the device.

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.

If you have any further questions, please don’t hesitate to contact us again.

Yours sincerely

Janne Aule

Dear Sir or Madam,

We are a manufacturer of class IIa medical devices according to Regulation (EU) 2017/745 in Liechtenstein and would like to distribute our products in Estonia.

Therefore, we would like to notify the Health Board via the EMDDB.

However, we do not have a distributor who is a holder of an Estonian ID card.

Could you please provide us with a temporary license to use the EMDDB?

Thank you and best regards,

Jae-Yeon Lepp